Withdrawal of Approval of 128 Suitability Petitions, 8184-8189 [E7-3043]

Download as PDF 8184 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,251 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by April 24, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 22, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 3, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–3128 Filed 2–22–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004P–0262] Withdrawal of Approval of 128 Suitability Petitions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 128 suitability petitions. This action is being taken in accordance with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA’s enactment, FDA had approved these suitability petitions to permit abbreviated new drug applications (ANDAs) to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs (RLDs). However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. This action is being taken without prejudice. Any of the suitability petitions may be resubmitted for action by the agency in accordance with current law. DATES: This notice is effective March 26, 2007. FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–5845. Petition No. PREA (Public Law 108–155) was enacted on December 3, 2003. Among other things, section 2 of PREA requires that all drug applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. As a result, FDA is withdrawing its approval for 128 suitability petitions for which ANDAS were never submitted. The approval decisions, made prior to the enactment of PREA, would have permitted ANDAs to be submitted for certain drugs that have a different active ingredient, dosage form, or route of administration than their RLDs. No ANDAs were submitted for these drugs pursuant to these suitability petitions prior to April 1, 1999, and any such application submitted on or after April 1, 1999, would be required to contain the safety and effectiveness assessments required by PREA, unless waived or deferred. According to § 314.93(e)(1)(i) (21 CFR 314.93(e)(1)(i)), a suitability petition may not be approved if investigations must be conducted to show the safety and effectiveness of the drug product. In addition, according to § 314.93(f), FDA may withdraw approval of a suitability petition if it receives information demonstrating that the petition no longer satisfies the conditions of § 314.93(e). Under PREA, safety and effectiveness investigations in pediatric subpopulations would be required for the drug products proposed by these suitability petitions, unless the requirement is waived or deferred. Therefore, these suitability petitions no longer satisfy the regulatory requirements for approval. Pursuant to § 314.93(f), FDA is withdrawing approval of the 128 suitability petitions listed in the following table: SUPPLEMENTARY INFORMATION: Drug Petitioner Chlorzoxazone 500 milligrams (mg) Mikart, Inc. 84N–0116/CP1 Disopyramide Phosphate 200 mg or 300 mg Biocraft Laboratories, Inc. 84P–0228/CP1 Acetaminophen 500 mg, Codeine Phosphate 30 mg or 60 mg McNeil Pharmaceutical 85P–0067/CP1 cprice-sewell on PROD1PC61 with NOTICES 82N–0032/CP6 Methyltestosterone 25 mg Star Pharmaceuticals 85P–0074/CP1 Hydralazine Hydrochloride 25 mg/5 milliliters (mL) Roxane Laboratories, Inc. 85P–0081/CP1 Flurazepam Hydrochloride 30 mg/mL Do. 85P–0084/CP1 Vincristine Sulfate 2 mg Bristol Laboratories VerDate Aug<31>2005 15:07 Feb 22, 2007 Jkt 211001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices Petition No. Drug 8185 Petitioner Flurazepam Hydrochloride 15 mg/5 mL Roxane Laboratories, Inc. 85P–0095/CP1 Brompheniramine Maleate 12 mg, Pseudoephedrine Hydrochloride 120 mg UAD Laboratories, Inc. 85P–0129/CP1 Propranolol Hydrochloride 160 mg Verex Laboratories, Inc. 85P–0140/CP1 Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Hydrochloride 120 mg Central Pharmaceuticals, Inc. 85P–0140/CP2 Dexbrompheniramine Maleate 6 mg, Pseudoephedrine Sulfate 120 mg Do. 85P–0147/CP1 Ketoconazole 20 mg/mL Janssen Pharmaceutica 85P–0197/CP1 Propranolol Hydrochloride 80 mg, 120 mg, 160 mg Forest Laboratories 85P–0215/CP1 Disulfiram 500 mg/30 mL Paddock Laboratories 85P–0238/CP2 Dexbrompheniramine Maleate 6 mg, Phenylpropanolamine Hydrochloride 75 mg Bock Pharmacal Co. 85P–0269/CP1 Codeine Phosphate 10 mg/5 mL, Dexbrompheniramine Maleate 1 mg/5 mL, Phenylpropanolamine Hydrochloride 12.5 mg/5 mL Do. 85P–0423/CP1 Benztropine Mesylate 0.5 mg/5 mL RIM Consulting Corp. 85P–0492/CP1 Azatadine Maleate 1 mg, Phenylpropanolamine Hydrochloride 75 mg Smith, Kline & French Laboratories 85P–0499/CP1 Diazepam 2 mg/5 mL Carolina Medical Products Co. 85P–0510/CP1 Spironolactone 25 mg/5 mL Do. 85P–0515/CP1 Lorazepam 0.5 mg, 1 mg, or 2 mg Wyeth Laboratories, Inc. 85P–0516/CP1 Oxazepam 15 mg or 30 mg Do. 85P–0543/CP1 Acetaminophen 300 mg, Codeine Phosphate 30 mg Softan, Inc. 85P–0543/CP2 Acetaminophen 500 mg, Codeine Phosphate 7.5 or 15 mg Do. 85P–0543/CP3 Acetaminophen 500 mg, Oxycodone Hydrochloride 5 mg Do. 85P–0563/CP1 Ibuprofen 300, 400, or 600 mg Do. 85P–0581/CP1 Acetaminophen 500 mg, Propoxyphene Hydrochloride 32 mg Do. 86P–0045/CP1 Propranolol Hydrochloride 10, 20, 40, 60, 80, 90 mg Nutripharm, Inc. 86P–0055/CP1 Spironolactone 25 mg/5 mL Carolina Medical Products Co. 86P–0123/CP1 Cholestyramine 4 grams (g) Parke-Davis, Division of Warner-Lambert Co. 86P–0200/CP1 Acetaminophen 650 mg, Codeine Phosphate 15 mg Mikart, Inc. 86P–0242/CP1 Floxuridine 500 mg/5 mL Quad Pharmaceuticals, Inc. 86P–0292/CP1 cprice-sewell on PROD1PC61 with NOTICES 85P–0091/CP1 Lorazepam 1 mg/5 mL Roxane Laboratories, Inc. 86P–0359/CP1 Aspirin 356.4 mg, Caffeine 30 mg, Dihydrocodeine Bitartrate 16 mg Central Pharmaceuticals, Inc. 86P–0361/CP1 Acetaminophen 325 mg, Aspirin 325 mg, Codeine Phosphate 30 mg Bock Pharmacal Co. VerDate Aug<31>2005 15:07 Feb 22, 2007 Jkt 211001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1 8186 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices Petition No. Drug Petitioner Hydrochlorothiazide 50 mg, Triamterene 75 mg Par Pharmaceutical, Inc. 86P–0474/CP1 Cholestyramine 500 mg Bristol-Myers Squibb 87P–0004/CP1 Fluocinonide 0.05% Richard Hamer Assoc. 87P–0037/CP1 Lorazepam 0.5 mg, 1 mg, 2 mg Applied Laboratories, Inc. 87P–0101/CP1 Verapamil Hydrochloride 40 mg/5 mL or 80 mg/5 mL MY-K Laboratories, Inc. 87P–0233/CP1 Verapamil Hydrochloride 120 mg or 240 mg Searle Research & Development 87P–0242/CP1 Ibuprofen 800 mg Sidmak Laboratories, Inc. 87P–0265/CP1 Dexbrompheniramine Maleate 6 mg, Phenypropanolamine Hydrochloride 75 mg Bock Pharmacal Co. (King & Spalding) 87P–0268/CP1 Loperamide Hydrochloride 2 mg Kross, Inc. 87P–0301/CP1 Cholestyramine Resin 4 g Ciba-Geigy Corp. 87P–0314/CP1 Clemastine Fumarate 1.34 mg, Pseudoephedrine Hydrochloride 120 mg Sandoz Consumer Healthcare Group 87P–0323/CP1 Acetaminophen 160 mg/5 mL, Codeine Phosphate 6 mg/5 mL Kleinfeld, Kaplan & Becker 87P–0335/CP1 Triamterene 50 mg, Hydrochlorothiazide 25 mg Par Pharmaceutical, Inc. 87P–0340/CP1 Nifedipine 10 mg or 20 mg Do. 87P–0367/CP1 Phenytoin Sodium 100 mg, 250 mg/vial Lyphomed, Inc. 87P–0399/CP1 Propranolol Hydrochloride 40 mg or 80 mg/5 mL, Hydrochlorothiazide 25 mg/5 mL Burditt, Bowles, Radzius & Rudberry 88P–0011/CP1 Cyclophosphamide 20 mg/mL, 500 mL pharmacy bulk pack (PBP) Baxter Healthcare Corp. 88P–0036/CP1 Chlorhexidine Gluconate 0.5% Arent, Fox, Kinter, Plotkin & Kahn 88P–0061/CP1 Homatropine Methylbromide 1.5 mg, Hydrocodone Bitartrate 5 mg Kleinfeld, Kaplan & Becker 88P–0149/CP1 Leucovorin Calcium 1 mg/mL Roxane Laboratories, Inc. 88P–0277/CP1 Quinidine Sulfate 300 mg A. H. Robins 88P–0350/CP1 Clemastine Fumarate 1.34 mg, Phenylpropanolamine Hydrochloride 75 mg Scientific Consulting of VA, Inc. 88P–0379/CP1 Cyclophosphamide 20 mg/mL, 250 mL PBP Baxter Healthcare Corp. 88P–0391/CP1 Prednisone 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 25 mg, or 50 mg B.F. Ascher & Co., Inc. 89P–0028/CP1 Hydrocortisone Valerate 0.2% McKenna, Conner & Cuneo 89P–0029/CP1 Hydrocortisone Valerate 0.2% Do. 89P–0071/CP1 Morphine Sulfate 30 mg Ethypharm/Oxford Research Intl. Corp. 89P–0399/CP1 Carbamazepine 200 mg/5 mL Guidelines, Inc. 89P–0435/CP1 Pentamidine Isethionate 100 mg/mL Astra Pharmaceutical Products, Inc. 90P–0049/CP1 cprice-sewell on PROD1PC61 with NOTICES 86P–0427/CP1 Hydrocortisone Acetate 2.5% or 1% Ferndale Laboratories, Inc. 90P–0084/CP1 Chlorzoxazone 250 mg Mikart, Inc. 90P–0154/CP1 Hydrocortisone Acetate 1% Ferndale Laboratories, Inc. 90P–0198/CP1 Clobetasol Propionate 0.05%, RLD = Temovate Kross, Inc. VerDate Aug<31>2005 15:07 Feb 22, 2007 Jkt 211001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices Petition No. Drug Petitioner Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co. 91P–0348/CP1 Albuterol Sulfate 4 mg Richard Hamer Associates, Inc. 92P–0048/CP2 Triazolam 0.125 mg/5 mL Roxane Laboratories, Inc. 92P–0101/CP1 Hydrocortisone Acetate 2.5% Hogan & Hartson 92P–0282/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 5 mg Mikart, Inc. 92P–0282/CP2 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 7.5 mg Do. 92P–0282/CP3 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 2.5 mg Do. 92P–0282/CP4 Acetaminophen 150 mg, Aspirin 180 mg, Hydrocodone Bitartrate 10 mg Do. 92P–0332/CP1 Propranolol Hydrochloride 40 mg Flemington Pharmaceutical Corp. 92P–0335/CP1 Albuterol Sulfate 2 mg, 4 mg WE Pharmaceuticals, Inc. 92P–0336/CP1 Prednisone 5 mg or 10 mg Do. 92P–0381/CP1 Cytarabine 20 mg/mL, 12.5 mL Bristol-Myers Squibb Co. 92P–0500/CP1 Timethoprim 25 mg/5 mL Ascent Pharmaceuticals, Inc. 93P–0048/CP1 Cimetidine 200, 300, 400 or 800 mg Flemington Pharmaceuticals Corp. 93P–0049/CP1 Propranolol Hydrochloride 10, 20, 60, 80, 90 mg Do. 93P–0314/CP1 Acetaminophen 500 mg, Codeine Phosphate 45 mg Mikart, Inc. 93P–0332/CP1 Loperamide Hydrochloride 1 mg Asta Medica GmbH 93P–0333/CP1 Prednisone 1, 2.5, 20, 50 mg Dura Pharmaceuticals 93P–0346/CP1 Acetaminophen 325 mg, Butalbital 50 mg, Caffeine 40 mg, Hydrocodone Bitartrate 5 mg Mikart, Inc. 93P–0367/CP1 Terfenadine 60 mg, Pseudoephedrine 120 mg Eurand America 93P–0446/CP1 Morphine Sulfate 15 mg, 60 mg, 90 mg, 100 mg Ethypharm 93P–0459/CP1 Methyltestosterone 25 mg ICN Pharmaceuticals, Inc. 94P–0182/CP1 Acetaminophen 120 mg, Codeine Phosphate 12 mg WE Pharmaceuticals, Inc. 94P–0186/CP1 Sulfamethoxazole 200 mg, Trimethoprim 40 mg Dura Pharmaceuticals 94P–0199/CP1 cprice-sewell on PROD1PC61 with NOTICES 90P–0436/CP1 Lorazepam 1 mg/10 mL Roxane Laboratories, Inc. 94P–0210/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 60 mg Mikart, Inc. 94P–0211/CP1 Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 30 mg Do. VerDate Aug<31>2005 15:07 Feb 22, 2007 Jkt 211001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1 8187 8188 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices Petition No. Drug Petitioner Acetaminophen 150 mg, Aspirin 180 mg, Codeine Phosphate 15 mg Do. 94P–0263/CP1 Fluorouracil 5% Bradley Pharmaceuticals, Inc. 94P–0432/CP1 Methylprednisolone 16 mg, 24 mg, 32 mg Dura Pharmaceuticals 94P–0433/CP1 Leucovorin Calcium 10 mg/mL 350 mg vial Lederle Laboratories 94P–0433/CP2 Leucovorin Calcium 10 mg/mL 5 mL vial Do. 95P–0008/CP1 Captopril 25 mg/mL Roxane Laboratories, Inc. 95P–0100/CP1 Carbidopa/Levodopa 25/100 mg, 25/250 mg Athena Neurosciences, Inc. 95P–0223/CP1 Hydrocortisone Butyrate 0.1% McKenna & Cuneo, L.L.P. 95P–0268/CP1 Acyclovir Sodium 5 mg/mL Wilmer, Cutler, Pickering 95P–0277/CP1 Cholestyramine 2 g Mayrand Pharmaceuticals, Inc. 95P–0279/CP1 Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mg Mikart, Inc. 95P–0279/CP2 Butalbital 50 mg, Acetaminophen 325 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mg Do. 95P–0279/CP3 Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 10 mg Do. 95P–0279/CP4 Butalbital 50 mg, Acetaminophen 500 mg, Caffeine 40 mg, Hydrocodone Bitartrate 7.5 mg Do. 95P–0326/CP1 Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co. 95P–0328/CP1 Metronidazole 0.75% RNB Pharmaceutical Co. 96P–0018/CP1 Potassium Chloride 20 milliequivalents (meq) KV Pharmaceutical Co. 96P–0021/CP1 Aspirin 650 mg Butalbital 50 mg Savage Laboratories, Division of Altana, Inc. 96P–0054/CP1 Potassium Chloride 10 meq KV Pharmaceutical Co. 96P–0079/CP1 Pentoxyfylline 400 mg Do. 96P–0307/CP1 Acyclovir 5% Pitney, Hardin, Kipp & Szuch 96P–0376/CP1 Hydrocortisone Acetate 90 mg Do. 96P–0510/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Cardiazem CD Labopharm, Inc. 97P–0155/CP1 Mefenamic Acid 250 mg Pitney, Hardin, Kipp & Szuch 97P–0192/CP1 cprice-sewell on PROD1PC61 with NOTICES 94P–0212/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Dilacor XR Labopharm, Inc. 97P–0195/CP1 Diltiazem Hydrochloride 120 mg, 180 mg, 240 mg, RLD = Tiazac Do. 97P–0387/CP1 Albuterol Sulfate 2 mg and 4 mg Richard Hamer Assoc., Inc. 97P–0404/CP1 Famotidine 10 mg Thomas Blake, R.Ph. VerDate Aug<31>2005 15:07 Feb 22, 2007 Jkt 211001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices Petition No. Drug Petitioner 98P–0068/CP1 Clobetasol Propionate 0.05%, RLD = Temovate E Richard Hamer Associates, Inc. 98P–0146/CP1 Ifosfamide 50 mg/mL, 20 mL, and 60 mL Mitchall G. Clark 98P–0199/CP1 Captopril 25 mg/5 mL Miran Consulting, Inc. 98P–0745/CP1 Econazole Nitrate 1% Do. This action is being taken without prejudice. Any of these petitions may be resubmitted for action by the agency in accordance with current law. Dated: February 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–3043 Filed 2–22–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. cprice-sewell on PROD1PC61 with NOTICES 8189 Proposed Project: Protection and Advocacy for Individuals with Mental Illness (PAIMI) Annual Program Performance Report (OMB No. 0930– 0169)—Revision The Protection and Advocacy for Individuals with Mental Illness (PAIMI) VerDate Aug<31>2005 15:07 Feb 22, 2007 Jkt 211001 Act, [42 U.S.C. 10801 et seq.] authorized funds to support protection and advocacy services on behalf of individuals with severe mental illness and severe emotional impairment who are at risk for abuse (including incidents of seclusion, restraint, and serious injuries or fatalities related to such incidents, neglect, residing in a public or private care or treatment facility. The PAIMI Program is managed by the Center for Mental Health Services (CMHS) within the Substance Abuse and Mental Health Services Administration (SAMHSA). Under the PAIMI Act, formula grant awards are made to governor-designated protection and advocacy (P&A) systems in each of the 50 states, the District of Columbia (Mayor), the American Indian Consortium [the Dine (Navajo) and Hopi Peoples in Northern Arizona and New Mexico), and five (5) territories— American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. The awards are used to provide legalbased advocacy services which ensure protection against violation of the constitutional and federal rights of individuals with significant (severe) mental illness (adults) and significant (severe) emotional impairment. In 2000, the PAIMI Act amendments, created a 57th P&A system—the American Indian Consortium and authorized P&A systems to serve PAIMIeligible individuals, as defined under the Act [42 U.S.C. at 10802 (4)], who reside in the community including their own homes. However, P&A services to PAIMI-eligible clients residing in the community is permissible only when the annual PAIMI appropriation met or exceeded $30 million, and that residents in public and private residential care or treatment facilities had service priority over community residents. The Children’s Health Act of 2000 (42 U.S.C. 290aa et seq.), also referenced State P&A authority to obtain information on incidents of seclusion, restraint, and related deaths in certain facilities. The PAIMI Act requires each of the 57 P & A systems to file an annual report, no later than January 1st, of its activities and accomplishments and to provide PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 information on such topics as, the numbers of individuals served, types of complaints addressed, and the number of intervention strategies used to resolve the presenting issues. Under the Act, the PAIMI Advisory Council (PAC) of each P&A system is also required to submit its independent assessment of the effectiveness of the services provided to, and the activities conducted by, the P&A systems on behalf of PAIMI-eligible individuals and their family members, in a separate section of the PPR. The Developmental Disabilities Assistance and Bill of Rights Act of 1975, referred to as the DD Act [42 U.S.C. 6042 et seq.], created the State P&A systems. The Administration on Developmental Disabilities, within the Administration for Children and Families, has administrative oversight of the Protection and Advocacy for Developmental Disabilities (PADD) Program. Since 1986, the Department has provided formula grant funds to the same governor-designated P&A systems to protect and advocate for individuals with significant mental illness. SAMHSA is currently waiting for the ADD to issue a Notice of Proposed Rulemaking (NPR) for the DD Act of 2000 amendments. These amendments will also govern activities fulfilled by the State P&A systems under the PAIMI Act. Therefore, to ensure to the greatest extent possible that all facets of the P&A system administered by the Department are subject to the same requirements, SAMHSA will wait until the DD Act NPR is published before revising the PAIMI Rules. [The Final PAIMI Rules were issued in 1997 and were extended in 2000 and 2004. An FRN was published May 2006 to extend the current PAIMI Rules, which will expire in 2007, until 2010]. The Substance Abuse Mental Health Services Administration (SAMHSA) is revising the PAIMI Annual Program Performance Report for the following reasons: (1) To make it consistent with the requirements of the annual reporting requirements under the PAIMI Act and the PAIMI Rules (42 CFR Part 51), as 2), and the CHA of 2000 Parts H and I; (2) to conform with the Office of Management and Budget ’s (OMB) E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8184-8189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P-0262]


Withdrawal of Approval of 128 Suitability Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 128 suitability petitions. This action is being taken in accordance 
with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's 
enactment, FDA had approved these suitability petitions to permit 
abbreviated new drug applications (ANDAs) to be submitted for drugs 
that had a different active ingredient, dosage form, or route of 
administration than their reference listed drugs (RLDs). However, these 
approval decisions are being withdrawn because ANDAs were never 
submitted and PREA requires that all applications submitted on or after 
April 1, 1999, for a new active ingredient, new indication, new dosage 
form, new dosing regimen, or new route of administration contain an 
assessment of the safety and effectiveness of the drug for the claimed 
indications in relevant pediatric subpopulations unless the requirement 
is waived or deferred. This action is being taken without prejudice. 
Any of the suitability petitions may be resubmitted for action by the 
agency in accordance with current law.

DATES: This notice is effective March 26, 2007.

FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5845.

SUPPLEMENTARY INFORMATION: PREA (Public Law 108-155) was enacted on 
December 3, 2003. Among other things, section 2 of PREA requires that 
all drug applications submitted on or after April 1, 1999, for a new 
active ingredient, new indication, new dosage form, new dosing regimen, 
or new route of administration contain an assessment of the safety and 
effectiveness of the drug for the claimed indications in relevant 
pediatric subpopulations unless the requirement is waived or deferred. 
As a result, FDA is withdrawing its approval for 128 suitability 
petitions for which ANDAS were never submitted. The approval decisions, 
made prior to the enactment of PREA, would have permitted ANDAs to be 
submitted for certain drugs that have a different active ingredient, 
dosage form, or route of administration than their RLDs. No ANDAs were 
submitted for these drugs pursuant to these suitability petitions prior 
to April 1, 1999, and any such application submitted on or after April 
1, 1999, would be required to contain the safety and effectiveness 
assessments required by PREA, unless waived or deferred. According to 
Sec.  314.93(e)(1)(i) (21 CFR 314.93(e)(1)(i)), a suitability petition 
may not be approved if investigations must be conducted to show the 
safety and effectiveness of the drug product. In addition, according to 
Sec.  314.93(f), FDA may withdraw approval of a suitability petition if 
it receives information demonstrating that the petition no longer 
satisfies the conditions of Sec.  314.93(e). Under PREA, safety and 
effectiveness investigations in pediatric subpopulations would be 
required for the drug products proposed by these suitability petitions, 
unless the requirement is waived or deferred. Therefore, these 
suitability petitions no longer satisfy the regulatory requirements for 
approval. Pursuant to Sec.  314.93(f), FDA is withdrawing approval of 
the 128 suitability petitions listed in the following table:

------------------------------------------------------------------------
  Petition
    No.                      Drug                       Petitioner
------------------------------------------------------------------------
82N-0032/    Chlorzoxazone 500 milligrams (mg)    Mikart, Inc.
 CP6
------------------------------------------------------------------------
84N-0116/    Disopyramide Phosphate 200 mg or     Biocraft Laboratories,
 CP1          300 mg                               Inc.
------------------------------------------------------------------------
84P-0228/    Acetaminophen 500 mg,                McNeil Pharmaceutical
 CP1         Codeine Phosphate 30 mg or 60 mg
------------------------------------------------------------------------
85P-0067/    Methyltestosterone 25 mg             Star Pharmaceuticals
 CP1
------------------------------------------------------------------------
85P-0074/    Hydralazine Hydrochloride 25 mg/5    Roxane Laboratories,
 CP1          milliliters (mL)                     Inc.
------------------------------------------------------------------------
85P-0081/    Flurazepam Hydrochloride 30 mg/mL    Do.
 CP1
------------------------------------------------------------------------
85P-0084/    Vincristine Sulfate 2 mg             Bristol Laboratories
 CP1
------------------------------------------------------------------------

[[Page 8185]]

 
85P-0091/    Flurazepam Hydrochloride 15 mg/5 mL  Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
85P-0095/    Brompheniramine Maleate 12 mg,       UAD Laboratories, Inc.
 CP1         Pseudoephedrine Hydrochloride 120
              mg
------------------------------------------------------------------------
85P-0129/    Propranolol Hydrochloride 160 mg     Verex Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
85P-0140/    Dexbrompheniramine Maleate 6 mg,     Central
 CP1         Pseudoephedrine Hydrochloride 120     Pharmaceuticals, Inc.
              mg
------------------------------------------------------------------------
85P-0140/    Dexbrompheniramine Maleate 6 mg,     Do.
 CP2         Pseudoephedrine Sulfate 120 mg
------------------------------------------------------------------------
85P-0147/    Ketoconazole 20 mg/mL                Janssen Pharmaceutica
 CP1
------------------------------------------------------------------------
85P-0197/    Propranolol Hydrochloride 80 mg,     Forest Laboratories
 CP1          120 mg, 160 mg
------------------------------------------------------------------------
85P-0215/    Disulfiram 500 mg/30 mL              Paddock Laboratories
 CP1
------------------------------------------------------------------------
85P-0238/    Dexbrompheniramine Maleate 6 mg,     Bock Pharmacal Co.
 CP2         Phenylpropanolamine Hydrochloride
              75 mg
------------------------------------------------------------------------
85P-0269/    Codeine Phosphate 10 mg/5 mL,        Do.
 CP1         Dexbrompheniramine Maleate 1 mg/5
              mL,
             Phenylpropanolamine Hydrochloride
              12.5 mg/5 mL
------------------------------------------------------------------------
85P-0423/    Benztropine Mesylate 0.5 mg/5 mL     RIM Consulting Corp.
 CP1
------------------------------------------------------------------------
85P-0492/    Azatadine Maleate 1 mg,              Smith, Kline & French
 CP1         Phenylpropanolamine Hydrochloride     Laboratories
              75 mg
------------------------------------------------------------------------
85P-0499/    Diazepam 2 mg/5 mL                   Carolina Medical
 CP1                                               Products Co.
------------------------------------------------------------------------
85P-0510/    Spironolactone 25 mg/5 mL            Do.
 CP1
------------------------------------------------------------------------
85P-0515/    Lorazepam 0.5 mg, 1 mg, or 2 mg      Wyeth Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
85P-0516/    Oxazepam 15 mg or 30 mg              Do.
 CP1
------------------------------------------------------------------------
85P-0543/    Acetaminophen 300 mg,                Softan, Inc.
 CP1         Codeine Phosphate 30 mg
------------------------------------------------------------------------
85P-0543/    Acetaminophen 500 mg,                Do.
 CP2         Codeine Phosphate 7.5 or 15 mg
------------------------------------------------------------------------
85P-0543/    Acetaminophen 500 mg,                Do.
 CP3         Oxycodone Hydrochloride 5 mg
------------------------------------------------------------------------
85P-0563/    Ibuprofen 300, 400, or 600 mg        Do.
 CP1
------------------------------------------------------------------------
85P-0581/    Acetaminophen 500 mg,                Do.
 CP1         Propoxyphene Hydrochloride 32 mg
------------------------------------------------------------------------
86P-0045/    Propranolol Hydrochloride 10, 20,    Nutripharm, Inc.
 CP1          40, 60, 80, 90 mg
------------------------------------------------------------------------
86P-0055/    Spironolactone 25 mg/5 mL            Carolina Medical
 CP1                                               Products Co.
------------------------------------------------------------------------
86P-0123/    Cholestyramine 4 grams (g)           Parke-Davis, Division
 CP1                                               of Warner-Lambert Co.
------------------------------------------------------------------------
86P-0200/    Acetaminophen 650 mg,                Mikart, Inc.
 CP1         Codeine Phosphate 15 mg
------------------------------------------------------------------------
86P-0242/    Floxuridine 500 mg/5 mL              Quad Pharmaceuticals,
 CP1                                               Inc.
------------------------------------------------------------------------
86P-0292/    Lorazepam 1 mg/5 mL                  Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
86P-0359/    Aspirin 356.4 mg,                    Central
 CP1         Caffeine 30 mg,                       Pharmaceuticals, Inc.
             Dihydrocodeine Bitartrate 16 mg
------------------------------------------------------------------------
86P-0361/    Acetaminophen 325 mg,                Bock Pharmacal Co.
 CP1         Aspirin 325 mg,
             Codeine Phosphate 30 mg
------------------------------------------------------------------------

[[Page 8186]]

 
86P-0427/    Hydrochlorothiazide 50 mg,           Par Pharmaceutical,
 CP1         Triamterene 75 mg                     Inc.
------------------------------------------------------------------------
86P-0474/    Cholestyramine 500 mg                Bristol-Myers Squibb
 CP1
------------------------------------------------------------------------
87P-0004/    Fluocinonide 0.05%                   Richard Hamer Assoc.
 CP1
------------------------------------------------------------------------
87P-0037/    Lorazepam 0.5 mg, 1 mg, 2 mg         Applied Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
87P-0101/    Verapamil Hydrochloride 40 mg/5 mL   MY-K Laboratories,
 CP1          or 80 mg/5 mL                        Inc.
------------------------------------------------------------------------
87P-0233/    Verapamil Hydrochloride 120 mg or    Searle Research &
 CP1          240 mg                               Development
------------------------------------------------------------------------
87P-0242/    Ibuprofen 800 mg                     Sidmak Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
87P-0265/    Dexbrompheniramine Maleate 6 mg,     Bock Pharmacal Co.
 CP1         Phenypropanolamine Hydrochloride 75   (King & Spalding)
              mg
------------------------------------------------------------------------
87P-0268/    Loperamide Hydrochloride 2 mg        Kross, Inc.
 CP1
------------------------------------------------------------------------
87P-0301/    Cholestyramine Resin 4 g             Ciba-Geigy Corp.
 CP1
------------------------------------------------------------------------
87P-0314/    Clemastine Fumarate 1.34 mg,         Sandoz Consumer
 CP1         Pseudoephedrine Hydrochloride 120     Healthcare Group
              mg
------------------------------------------------------------------------
87P-0323/    Acetaminophen 160 mg/5 mL,           Kleinfeld, Kaplan &
 CP1         Codeine Phosphate 6 mg/5 mL           Becker
------------------------------------------------------------------------
87P-0335/    Triamterene 50 mg,                   Par Pharmaceutical,
 CP1         Hydrochlorothiazide 25 mg             Inc.
------------------------------------------------------------------------
87P-0340/    Nifedipine 10 mg or 20 mg            Do.
 CP1
------------------------------------------------------------------------
87P-0367/    Phenytoin Sodium 100 mg, 250 mg/     Lyphomed, Inc.
 CP1          vial
------------------------------------------------------------------------
87P-0399/    Propranolol Hydrochloride 40 mg or   Burditt, Bowles,
 CP1          80 mg/5 mL,                          Radzius & Rudberry
             Hydrochlorothiazide 25 mg/5 mL
------------------------------------------------------------------------
88P-0011/    Cyclophosphamide 20 mg/mL, 500 mL    Baxter Healthcare
 CP1          pharmacy bulk pack (PBP)             Corp.
------------------------------------------------------------------------
88P-0036/    Chlorhexidine Gluconate 0.5%         Arent, Fox, Kinter,
 CP1                                               Plotkin & Kahn
------------------------------------------------------------------------
88P-0061/    Homatropine Methylbromide 1.5 mg,    Kleinfeld, Kaplan &
 CP1         Hydrocodone Bitartrate 5 mg           Becker
------------------------------------------------------------------------
88P-0149/    Leucovorin Calcium 1 mg/mL           Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
88P-0277/    Quinidine Sulfate 300 mg             A. H. Robins
 CP1
------------------------------------------------------------------------
88P-0350/    Clemastine Fumarate 1.34 mg,         Scientific Consulting
 CP1         Phenylpropanolamine Hydrochloride     of VA, Inc.
              75 mg
------------------------------------------------------------------------
88P-0379/    Cyclophosphamide 20 mg/mL, 250 mL    Baxter Healthcare
 CP1          PBP                                  Corp.
------------------------------------------------------------------------
88P-0391/    Prednisone 1 mg, 2.5 mg, 5 mg, 10    B.F. Ascher & Co.,
 CP1          mg, 20 mg, 25 mg, or 50 mg           Inc.
------------------------------------------------------------------------
89P-0028/    Hydrocortisone Valerate 0.2%         McKenna, Conner &
 CP1                                               Cuneo
------------------------------------------------------------------------
89P-0029/    Hydrocortisone Valerate 0.2%         Do.
 CP1
------------------------------------------------------------------------
89P-0071/    Morphine Sulfate 30 mg               Ethypharm/Oxford
 CP1                                               Research Intl. Corp.
------------------------------------------------------------------------
89P-0399/    Carbamazepine 200 mg/5 mL            Guidelines, Inc.
 CP1
------------------------------------------------------------------------
89P-0435/    Pentamidine Isethionate 100 mg/mL    Astra Pharmaceutical
 CP1                                               Products, Inc.
------------------------------------------------------------------------
90P-0049/    Hydrocortisone Acetate 2.5% or 1%    Ferndale Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
90P-0084/    Chlorzoxazone 250 mg                 Mikart, Inc.
 CP1
------------------------------------------------------------------------
90P-0154/    Hydrocortisone Acetate 1%            Ferndale Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
90P-0198/    Clobetasol Propionate 0.05%,         Kross, Inc.
 CP1         RLD = Temovate
------------------------------------------------------------------------

[[Page 8187]]

 
90P-0436/    Nifedipine 30 mg, 60 mg, 90 mg       KV Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
91P-0348/    Albuterol Sulfate 4 mg               Richard Hamer
 CP1                                               Associates, Inc.
------------------------------------------------------------------------
92P-0048/    Triazolam 0.125 mg/5 mL              Roxane Laboratories,
 CP2                                               Inc.
------------------------------------------------------------------------
92P-0101/    Hydrocortisone Acetate 2.5%          Hogan & Hartson
 CP1
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Mikart, Inc.
 CP1         Aspirin 180 mg,
             Hydrocodone Bitartrate 5 mg
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Do.
 CP2         Aspirin 180 mg,
             Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Do.
 CP3         Aspirin 180 mg,
             Hydrocodone Bitartrate 2.5 mg
------------------------------------------------------------------------
92P-0282/    Acetaminophen 150 mg,                Do.
 CP4         Aspirin 180 mg,
             Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
92P-0332/    Propranolol Hydrochloride 40 mg      Flemington
 CP1                                               Pharmaceutical Corp.
------------------------------------------------------------------------
92P-0335/    Albuterol Sulfate 2 mg, 4 mg         WE Pharmaceuticals,
 CP1                                               Inc.
------------------------------------------------------------------------
92P-0336/    Prednisone 5 mg or 10 mg             Do.
 CP1
------------------------------------------------------------------------
92P-0381/    Cytarabine 20 mg/mL, 12.5 mL         Bristol-Myers Squibb
 CP1                                               Co.
------------------------------------------------------------------------
92P-0500/    Timethoprim 25 mg/5 mL               Ascent
 CP1                                               Pharmaceuticals, Inc.
------------------------------------------------------------------------
93P-0048/    Cimetidine 200, 300, 400 or 800 mg   Flemington
 CP1                                               Pharmaceuticals Corp.
------------------------------------------------------------------------
93P-0049/    Propranolol Hydrochloride 10, 20,    Do.
 CP1          60, 80, 90 mg
------------------------------------------------------------------------
93P-0314/    Acetaminophen 500 mg,                Mikart, Inc.
 CP1         Codeine Phosphate 45 mg
------------------------------------------------------------------------
93P-0332/    Loperamide Hydrochloride 1 mg        Asta Medica GmbH
 CP1
------------------------------------------------------------------------
93P-0333/    Prednisone 1, 2.5, 20, 50 mg         Dura Pharmaceuticals
 CP1
------------------------------------------------------------------------
93P-0346/    Acetaminophen 325 mg,                Mikart, Inc.
 CP1         Butalbital 50 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 5 mg
------------------------------------------------------------------------
93P-0367/    Terfenadine 60 mg,                   Eurand America
 CP1         Pseudoephedrine 120 mg
------------------------------------------------------------------------
93P-0446/    Morphine Sulfate 15 mg, 60 mg, 90    Ethypharm
 CP1          mg, 100 mg
------------------------------------------------------------------------
93P-0459/    Methyltestosterone 25 mg             ICN Pharmaceuticals,
 CP1                                               Inc.
------------------------------------------------------------------------
94P-0182/    Acetaminophen 120 mg,                WE Pharmaceuticals,
 CP1         Codeine Phosphate 12 mg               Inc.
------------------------------------------------------------------------
94P-0186/    Sulfamethoxazole 200 mg,             Dura Pharmaceuticals
 CP1         Trimethoprim 40 mg
------------------------------------------------------------------------
94P-0199/    Lorazepam 1 mg/10 mL                 Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
94P-0210/    Acetaminophen 150 mg,                Mikart, Inc.
 CP1         Aspirin 180 mg,
             Codeine Phosphate 60 mg
------------------------------------------------------------------------
94P-0211/    Acetaminophen 150 mg,                Do.
 CP1         Aspirin 180 mg,
             Codeine Phosphate 30 mg
------------------------------------------------------------------------

[[Page 8188]]

 
94P-0212/    Acetaminophen 150 mg,                Do.
 CP1         Aspirin 180 mg,
             Codeine Phosphate 15 mg
------------------------------------------------------------------------
94P-0263/    Fluorouracil 5%                      Bradley
 CP1                                               Pharmaceuticals, Inc.
------------------------------------------------------------------------
94P-0432/    Methylprednisolone 16 mg, 24 mg, 32  Dura Pharmaceuticals
 CP1          mg
------------------------------------------------------------------------
94P-0433/    Leucovorin Calcium 10 mg/mL 350 mg   Lederle Laboratories
 CP1          vial
------------------------------------------------------------------------
94P-0433/    Leucovorin Calcium 10 mg/mL 5 mL     Do.
 CP2          vial
------------------------------------------------------------------------
95P-0008/    Captopril 25 mg/mL                   Roxane Laboratories,
 CP1                                               Inc.
------------------------------------------------------------------------
95P-0100/    Carbidopa/Levodopa 25/100 mg, 25/    Athena Neurosciences,
 CP1          250 mg                               Inc.
------------------------------------------------------------------------
95P-0223/    Hydrocortisone Butyrate 0.1%         McKenna & Cuneo,
 CP1                                               L.L.P.
------------------------------------------------------------------------
95P-0268/    Acyclovir Sodium 5 mg/mL             Wilmer, Cutler,
 CP1                                               Pickering
------------------------------------------------------------------------
95P-0277/    Cholestyramine 2 g                   Mayrand
 CP1                                               Pharmaceuticals, Inc.
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Mikart, Inc.
 CP1         Acetaminophen 325 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Do.
 CP2         Acetaminophen 325 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Do.
 CP3         Acetaminophen 500 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
95P-0279/    Butalbital 50 mg,                    Do.
 CP4         Acetaminophen 500 mg,
             Caffeine 40 mg,
             Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
95P-0326/    Nifedipine 30 mg, 60 mg, 90 mg       KV Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
95P-0328/    Metronidazole 0.75%                  RNB Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
96P-0018/    Potassium Chloride 20                KV Pharmaceutical Co.
 CP1          milliequivalents (meq)
------------------------------------------------------------------------
96P-0021/    Aspirin 650 mg                       Savage Laboratories,
 CP1         Butalbital 50 mg                      Division of Altana,
                                                   Inc.
------------------------------------------------------------------------
96P-0054/    Potassium Chloride 10 meq            KV Pharmaceutical Co.
 CP1
------------------------------------------------------------------------
96P-0079/    Pentoxyfylline 400 mg                Do.
 CP1
------------------------------------------------------------------------
96P-0307/    Acyclovir 5%                         Pitney, Hardin, Kipp &
 CP1                                               Szuch
------------------------------------------------------------------------
96P-0376/    Hydrocortisone Acetate 90 mg         Do.
 CP1
------------------------------------------------------------------------
96P-0510/    Diltiazem Hydrochloride 120 mg, 180  Labopharm, Inc.
 CP1          mg, 240 mg,
             RLD = Cardiazem CD
------------------------------------------------------------------------
97P-0155/    Mefenamic Acid 250 mg                Pitney, Hardin, Kipp &
 CP1                                               Szuch
------------------------------------------------------------------------
97P-0192/    Diltiazem Hydrochloride 120 mg, 180  Labopharm, Inc.
 CP1          mg, 240 mg,
             RLD = Dilacor XR
------------------------------------------------------------------------
97P-0195/    Diltiazem Hydrochloride 120 mg, 180  Do.
 CP1          mg, 240 mg,
             RLD = Tiazac
------------------------------------------------------------------------
97P-0387/    Albuterol Sulfate 2 mg and 4 mg      Richard Hamer Assoc.,
 CP1                                               Inc.
------------------------------------------------------------------------
97P-0404/    Famotidine 10 mg                     Thomas Blake, R.Ph.
 CP1
------------------------------------------------------------------------

[[Page 8189]]

 
98P-0068/    Clobetasol Propionate 0.05%,         Richard Hamer
 CP1         RLD = Temovate E                      Associates, Inc.
------------------------------------------------------------------------
98P-0146/    Ifosfamide 50 mg/mL, 20 mL, and 60   Mitchall G. Clark
 CP1          mL
------------------------------------------------------------------------
98P-0199/    Captopril 25 mg/5 mL                 Miran Consulting, Inc.
 CP1
------------------------------------------------------------------------
98P-0745/    Econazole Nitrate 1%                 Do.
 CP1
------------------------------------------------------------------------

    This action is being taken without prejudice. Any of these 
petitions may be resubmitted for action by the agency in accordance 
with current law.

    Dated: February 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3043 Filed 2-22-07; 8:45 am]
BILLING CODE 4160-01-S
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