Determination That TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 22960-22961 [E8-9161]

Download as PDF 22960 Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices 2008, and should submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 9, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 18, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–9177 Filed 4–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0238] Determination That TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that the 19 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new NDA No. drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved or (2) whenever a listed drug is voluntarily withdrawn from sale, and ANDAs that refer to the listed drug have been approved. Section 314.161(d) provides that if FDA determines that a listed drug was removed from sale for safety or effectiveness reasons, the agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. (As requested by the applicants, FDA withdrew approval of NDA 7–517 for TAPAZOLE Tablets in the Federal Register of November 7, 2007 (72 FR 62858), NDA 18–754 for ORUDIS Capsules in the Federal Register of June 16, 2006 (71 FR 34940), NDA 18–062 for PROVENTIL Syrup in the Federal Register of March 4, 2005 (70 FR 10651), and NDA 8–604 for PHENERGAN VC Syrup in the Federal Register of May 5, 2004 (69 FR 25124). Drug Applicant TAPAZOLE (methimazole) Tablets, 5 milligrams (mg) and 10 mg King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620 7–935 pwalker on PROD1PC71 with NOTICES 7–517 PHENERGAN (promethazine hydrochloride (HCl)) Tablets, 25 mg Wyeth Pharmaceuticals,Inc., P.O. Box 8299, Philadelphia, PA 19101–8299 8–306 PHENERGAN with Codeine (codeine phosphate and promethazine HCl) Syrup, 6.25 mg/5 milliliters (mL), 10 mg/5 mL ANI Pharmaceuticals, Inc., 7131 Ambassador Rd., Woodlawn, MD 21244 VerDate Aug<31>2005 18:22 Apr 25, 2008 Jkt 214001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices NDA No. Drug 22961 Applicant PHENERGAN VC with Codeine (codeine phosphate; phenylephrine HCl; promethazine HCl) Syrup, 5 mg/5 mL; 6.25 mg/5 mL; 10 mg/5 mL Do. 8–381 PHENERGAN FORTIS (promethazine HCl) Syrup, 25 mg/5 mL Do. 8–381 PHENERGAN Plain (promethazine HCl) Syrup, 6.25 mg/ 5 mL Do. 8–604 PHENERGAN VC (phenylephrine HCl; promethazine HCl) Syrup, 5 mg/5 mL; 6.25 mg/5 mL Do. 9–000 CAFERGOT (caffeine; ergotamine tartrate) Suppository, 100 mg/2 mg Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936–1080 9–509 ARAMINE (metaraminol bitartrate) Injection, equivalent to (EQ) 10 mg base/mL Merck & Co., Inc., 770 Sumneytown Pike, BLA–20, P.O. Box 4, West Point, PA 19486 11–265 PHENERGAN with Dextromethorphan (dextromethorphan hydrobromide; promethazine HCl) Syrup, 6.25 mg/5 mL; 15 mg/5 mL ANI 11–459 VISTARIL (hydroxyzine pamoate EQ hydroxyzine HCl) Capsules, 100 mg Pfizer, Inc., 235 East 42nd St., New York, NY 10017 11–689 PHENERGAN (promethazine HCl) Suppository, 50 mg Wyeth 12–125 CARBOCAINE (mepivacaine HCl) Injection, 3 % (30 mg/ mL/1.8 mL cartridge) Eastman Kodak Co., Dental Products, 343 State St., Rochester, NY 14612–1122 18–062 PROVENTIL (albuterol sulfate) Syrup, EQ 2 mg base/ 5mL Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 18–152 ESKALITH CR (lithium carbonate) Extended Release Tablets, 450 mg GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101–7929 18–200 MIDAMOR (amiloride HCl) Tablets, 5 mg Merck 18–201 MODURETIC 5–50 (amiloride HCl; hydrochlorothiazide) Tablets, 5 mg/50 mg Merck 18–754 ORUDIS (ketoprofen) Capsules, 25 mg, 50 mg, and 75 mg Wyeth 20–460 pwalker on PROD1PC71 with NOTICES 8–306 CYTOVENE (ganciclovir) Capsules, 250 mg and 500 mg Roche Laboratories, Inc., 340 Kingsland St., Nutley, NJ 07110–1199 FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs for the products may also be approved by the agency if they comply with relevant VerDate Aug<31>2005 18:22 Apr 25, 2008 Jkt 214001 legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: April 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–9161 Filed 4–25–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 73 FR 12742–12744 dated March 10, 2008). This notice reflects organizational changes in the Health Resources and Services Administration. Specifically, this notice moves the Office of Management (RS) under the Immediate E:\FR\FM\28APN1.SGM 28APN1

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[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Notices]
[Pages 22960-22961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9161]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0238]


Determination That TAPAZOLE Tablets and 18 Other Drug Products 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that the 
19 drug products listed in this document were not withdrawn from sale 
for reasons of safety or effectiveness. This determination means that 
FDA will not begin procedures to withdraw approval of abbreviated new 
drug applications (ANDAs) that refer to the drug products, and it will 
allow FDA to continue to approve ANDAs that refer to the products as 
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 
301-796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), 
which requires FDA to publish a list of all approved drugs. FDA 
publishes this list as part of the ``Approved Drug Products With 
Therapeutic Equivalence Evaluations,'' which is generally known as the 
``Orange Book.'' Under FDA regulations, drugs are withdrawn from the 
list if the agency withdraws or suspends approval of the drug's NDA or 
ANDA for reasons of safety or effectiveness, or if FDA determines that 
the listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved or (2) whenever a listed drug is voluntarily 
withdrawn from sale, and ANDAs that refer to the listed drug have been 
approved. Section 314.161(d) provides that if FDA determines that a 
listed drug was removed from sale for safety or effectiveness reasons, 
the agency will initiate proceedings that could result in the 
withdrawal of approval of the ANDAs that refer to the listed drug.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed. (As requested by the 
applicants, FDA withdrew approval of NDA 7-517 for TAPAZOLE Tablets in 
the Federal Register of November 7, 2007 (72 FR 62858), NDA 18-754 for 
ORUDIS Capsules in the Federal Register of June 16, 2006 (71 FR 34940), 
NDA 18-062 for PROVENTIL Syrup in the Federal Register of March 4, 2005 
(70 FR 10651), and NDA 8-604 for PHENERGAN VC Syrup in the Federal 
Register of May 5, 2004 (69 FR 25124).

------------------------------------------------------------------------
    NDA No.                 Drug                      Applicant
------------------------------------------------------------------------
7-517           TAPAZOLE (methimazole)       King Pharmaceuticals, Inc.,
                 Tablets, 5 milligrams (mg)   501 Fifth St., Bristol, TN
                 and 10 mg                    37620
------------------------------------------------------------------------
7-935           PHENERGAN (promethazine      Wyeth Pharmaceuticals,Inc.,
                 hydrochloride (HCl))         P.O. Box 8299,
                 Tablets, 25 mg               Philadelphia, PA 19101-
                                              8299
------------------------------------------------------------------------
8-306           PHENERGAN with Codeine       ANI Pharmaceuticals, Inc.,
                 (codeine phosphate and       7131 Ambassador Rd.,
                 promethazine HCl) Syrup,     Woodlawn, MD 21244
                 6.25 mg/5 milliliters
                 (mL), 10 mg/5 mL
------------------------------------------------------------------------

[[Page 22961]]

 
8-306           PHENERGAN VC with Codeine    Do.
                 (codeine phosphate;
                 phenylephrine HCl;
                 promethazine HCl) Syrup, 5
                 mg/5 mL; 6.25 mg/5 mL; 10
                 mg/5 mL
------------------------------------------------------------------------
8-381           PHENERGAN FORTIS             Do.
                 (promethazine HCl) Syrup,
                 25 mg/5 mL
------------------------------------------------------------------------
8-381           PHENERGAN Plain              Do.
                 (promethazine HCl) Syrup,
                 6.25 mg/5 mL
------------------------------------------------------------------------
8-604           PHENERGAN VC (phenylephrine  Do.
                 HCl; promethazine HCl)
                 Syrup, 5 mg/5 mL; 6.25 mg/
                 5 mL
------------------------------------------------------------------------
9-000           CAFERGOT (caffeine;          Novartis Pharmaceuticals
                 ergotamine tartrate)         Corp., One Health Plaza,
                 Suppository, 100 mg/2 mg     East Hanover, NJ 07936-
                                              1080
------------------------------------------------------------------------
9-509           ARAMINE (metaraminol         Merck & Co., Inc., 770
                 bitartrate) Injection,       Sumneytown Pike, BLA-20,
                 equivalent to (EQ) 10 mg     P.O. Box 4, West Point, PA
                 base/mL                      19486
------------------------------------------------------------------------
11-265          PHENERGAN with               ANI
                 Dextromethorphan
                 (dextromethorphan
                 hydrobromide; promethazine
                 HCl) Syrup, 6.25 mg/5 mL;
                 15 mg/5 mL
------------------------------------------------------------------------
11-459          VISTARIL (hydroxyzine        Pfizer, Inc., 235 East
                 pamoate EQ hydroxyzine       42\nd\ St., New York, NY
                 HCl) Capsules, 100 mg        10017
------------------------------------------------------------------------
11-689          PHENERGAN (promethazine      Wyeth
                 HCl) Suppository, 50 mg
------------------------------------------------------------------------
12-125          CARBOCAINE (mepivacaine      Eastman Kodak Co., Dental
                 HCl) Injection, 3 % (30 mg/  Products, 343 State St.,
                 mL/1.8 mL cartridge)         Rochester, NY 14612-1122
------------------------------------------------------------------------
18-062          PROVENTIL (albuterol         Schering Corp., 2000
                 sulfate) Syrup, EQ 2 mg      Galloping Hill Rd.,
                 base/5mL                     Kenilworth, NJ 07033
------------------------------------------------------------------------
18-152          ESKALITH CR (lithium         GlaxoSmithKline, One
                 carbonate) Extended          Franklin Plaza, P.O. Box
                 Release Tablets, 450 mg      7929, Philadelphia, PA
                                              19101-7929
------------------------------------------------------------------------
18-200          MIDAMOR (amiloride HCl)      Merck
                 Tablets, 5 mg
------------------------------------------------------------------------
18-201          MODURETIC 5-50 (amiloride    Merck
                 HCl; hydrochlorothiazide)
                 Tablets, 5 mg/50 mg
------------------------------------------------------------------------
18-754          ORUDIS (ketoprofen)          Wyeth
                 Capsules, 25 mg, 50 mg,
                 and 75 mg
------------------------------------------------------------------------
20-460          CYTOVENE (ganciclovir)       Roche Laboratories, Inc.,
                 Capsules, 250 mg and 500     340 Kingsland St., Nutley,
                 mg                           NJ 07110-1199
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list the drug products listed 
in this document in the ``Discontinued Drug Product List'' section of 
the Orange Book. The ``Discontinued Drug Product List'' identifies, 
among other items, drug products that have been discontinued from 
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. Additional ANDAs for the products may also be approved by 
the agency if they comply with relevant legal and regulatory 
requirements. If FDA determines that labeling for these drug products 
should be revised to meet current standards, the agency will advise 
ANDA applicants to submit such labeling.

    Dated: April 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9161 Filed 4-25-08; 8:45 am]
BILLING CODE 4160-01-S

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