Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 48352-48353 [2010-19638]

Download as PDF 48352 Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices sroberts on DSKB9S0YB1PROD with NOTICES (Organon), and was initially approved on October 5, 1962. Under the Drug Efficacy Study Implementation (DESI), FDA concluded that nandrolone decanoate was effective for the indications described in the Federal Register notice published on July 15, 1983 (DESI 7630, 48 FR 32394). DECADURABOLIN is an anabolic steroid indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Organon notified FDA in a letter dated May 21, 2002, that it was no longer marketing DECADURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, and the drug product was moved to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. PharmaForce, Inc., submitted a citizen petition dated May 7, 2009 (Docket No. FDA–2009–P–0218), under 21 CFR 10.30 requesting that the agency determine whether DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was withdrawn from sale for reasons of safety or effectiveness. FDA has reviewed its records and, under § 314.161, has determined that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was withdrawn for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list DECADURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, may be approved by the agency if all other legal and regulatory requirements for the approval of ANDAs are met. If FDA determines that labeling for this drug product should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: August 5, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–19698 Filed 8–9–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0391] Determination That MOTRIN (Ibuprofen) Tablets and Four Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the five 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 these 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. SUMMARY: FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug Evaluation and Research, 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 applicants must, with certain Application No. 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. ANDA applicants 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, a drug is 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; (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved; and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for reasons of safety or effectiveness, 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 applicant, FDA withdrew approval of NDA 18–354 for ORTHO–NOVUM 10/11–21 and 10/11– 28 (ethinyl estradiol; norethindrone) Tablets in the Federal Register of February 11, 2009 (74 FR 6896).) Drug Applicant NDA 17–463 MOTRIN (ibuprofen) Tablets, 300 milligrams (mg), 400 mg, 600 mg, and 800 mg McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034 NDA 18–303 LOPRESSOR HCT (hydrochlorothiazide; metoprolol tartrate ) Tablets, 50 mg; 100 mg Novartis Pharmaceuticals Corp., 59 Rte. 10, East Hanover, NJ 07936–1080 VerDate Mar<15>2010 16:26 Aug 09, 2010 Jkt 220001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1 48353 Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices Application No. Drug Applicant NDA 18–354 ORTHO-NOVUM 10/11–21 and 10/11–28 (ethinyl estradiol; norethindrone) Tablets, 0.035 mg, 0.035 mg; 0.5 mg, 1 mg Ortho McNeil Janssen Pharmaceuticals, Inc., 1125 Trenton Harbourton Rd., Titusville, NJ 08560 NDA 18–423 HIBICLENS (chlorhexidine gluconate) Topical Sponge, 4% Molnycke Health Care, 5550 Peachtree Parkway, Ste. 500, Norcross, GA 30092 NDA 19–436 PRIMACOR (milrinone lactate) Injection, Equivalent to (EQ) 1 mg base/milliliter Sanofi Aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807 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 that refer to these 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: July 29, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–19638 Filed 8–9–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–F–0320] United States Pharmacopeial Convention; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that the U.S. Pharmacopeial Convention has filed a petition proposing that the food additive regulations that SUMMARY: incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition. FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food Safety and Applied Nutrition (HFS– 265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 301–436–1278. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 0A4782) has been filed by U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852. The petition proposes that the food additive regulations in table 1 of this document, which incorporate by reference food-grade specifications from prior editions of the FCC, be amended to incorporate by reference food-grade specifications from the FCC, 7th Edition. TABLE 1.—LIST OF REGULATIONS 21 CFR Section FCC Edition and/or Supplement Currently Referenced Name of Additive Current FCC Reference 6th Ed. Hydrogen peroxide Meets FCC specifications. 172.320(b)(1) 3d Ed. Amino acids Meets FCC specifications. 172.345(b) 4th Ed. Folic acid (folacin) Meets FCC specifications. 172.379(b) 6th Ed. Vitamin D2 Meets FCC specifications. 172.380(b) 5th Ed. Vitamin D3 Meets FCC specifications. 172.665(d)(2) 4th Ed. Gellan gum Residual isopropyl alcohol limit not to exceed 0.075% by the procedure described in the Xanthan Gum monograph. 172.712(b) 4th Ed. 1,3-Butylene glycol Conforms to FCC identity and specifications. 172.723(b)(3) sroberts on DSKB9S0YB1PROD with NOTICES 172.167(b) 4th Ed. Epoxidized soybean oil Heavy metals (as lead) content cannot be more than 10 parts per million (ppm) as determined by the ‘‘Heavy Metals Test.’’ 172.736(b)(2) 5th Ed. Glycerides and polyglycides of hydrogenated vegetable oils Acid value not greater than 2, and hydroxyl value, not greater than 56 as determined by ‘‘Acid Value’’ and ‘‘Hydroxyl Value’’ methods. VerDate Mar<15>2010 16:26 Aug 09, 2010 Jkt 220001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\10AUN1.SGM 10AUN1

Agencies

[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48352-48353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0391]


Determination That MOTRIN (Ibuprofen) Tablets and Four 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 
five 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 these 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 Pritzlaff, Center for Drug 
Evaluation and Research, 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 
applicants 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. ANDA applicants 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, a drug is 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; (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved; and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for reasons 
of safety or effectiveness, 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 
applicant, FDA withdrew approval of NDA 18-354 for ORTHO-NOVUM 10/11-21 
and 10/11-28 (ethinyl estradiol; norethindrone) Tablets in the Federal 
Register of February 11, 2009 (74 FR 6896).)

--------------------------------------------------------------------------------------------------------------------------------------------------------
                Application No.                                         Drug                                              Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 17-463                                         MOTRIN (ibuprofen) Tablets, 300 milligrams (mg),      McNeil Consumer Healthcare, 7050 Camp Hill Rd.,
                                                                         400 mg, 600 mg, and 800 mg                            Fort Washington, PA 19034
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 18-303                                           LOPRESSOR HCT (hydrochlorothiazide; metoprolol     Novartis Pharmaceuticals Corp., 59 Rte. 10, East
                                                                  tartrate ) Tablets, 50 mg; 100 mg                               Hanover, NJ 07936-1080
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 48353]]

 
NDA 18-354                                               ORTHO-NOVUM 10/11-21 and 10/11-28 (ethinyl     Ortho McNeil Janssen Pharmaceuticals, Inc., 1125
                                                 estradiol; norethindrone) Tablets, 0.035 mg, 0.035         Trenton Harbourton Rd., Titusville, NJ 08560
                                                                                   mg; 0.5 mg, 1 mg
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 18-423                                      HIBICLENS (chlorhexidine gluconate) Topical Sponge,   Molnycke Health Care, 5550 Peachtree Parkway, Ste.
                                                                                                4 %                              500, Norcross, GA 30092
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 19-436                                       PRIMACOR (milrinone lactate) Injection, Equivalent           Sanofi Aventis U.S. LLC, 55 Corporate Dr.,
                                                                       to (EQ) 1 mg base/milliliter                                Bridgewater, NJ 08807
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 that refer to these 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: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19638 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S

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