Determination That ATROVENT (Ipatropium Bromide) Inhalation Solution and 10 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Oct 01, 2008 (FIND, Inc. via COMTEX) -- DPRD | Quote | Chart | News | PowerRating -- SUMMARY: The Food and Drug Administration (FDA) has determined that the 11 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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

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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 Under FDA regulations, a drug is withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 [Section] 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 [Section] 10.25(a) and [Section] 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 20-228 for ATROVENT (ipratropium bromide) Inhalation Solution in the Federal Register of November 7, 2007 (72 FR 62858).)

Table 1.--Approved TEQUIN Products Application No. Drug Applicant NDA 20-228 ATROVENT (ipratropium Boehringer Ingelheim bromide) Inhalation Pharmaceuticals, Inc., Solution, 0.02% 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368 NDA 20-306 Fludeoxyglucose F-18 Downstate Clinical PET (4-40 millicuries Center, Methodist Medical (mCi)/milliliter (mL) and Center, 112 Crescent 4-90 mCi/mL) Injection Ave., Peoria, IL 61606 NDA 20-333 AGRYLIN (anagrelide Shire US Inc., 725 hydrochloride (HCl)) Chesterbrook Blvd., Capsules, equivalent to Wayne, PA 19087-5637 (EQ) 1 milligram (mg) base NDA 20-377 CORDARONE (amiodarone Wyeth Pharmaceuticals, HCl) Injection, 50 mg/mL P.O. Box 8299, Philadelphia, PA 19101-8299 NDA 20-974 PROZAC (fluoxetine HCl) Eli Lilly and Co., Lilly Tablets, EQ 10 mg base Corporate Center, Indianapolis, IN 46285 NDA 50-417 NEOSPORIN (bacitracin Monarch Pharmaceuticals, zinc; neomycin sulfate; Inc., c/o King polymyxin B sulfate) Pharmaceuticals, Inc., Ophthalmic Ointment, 400 501 Fifth St., Bristol, units/gram (g); EQ 3.5 mg TN 37620 base/g; 10,000 units/g NDA 50-461 ANCEF (cefazolin sodium) GlaxoSmithKline, 2301 Injection, 250 mg/vial, Renaissance Blvd., King 500 mg/vial, and 5 g/vial of Prussia, PA 19406 NDA 50-521 CECLOR (cefaclor) Eli Lilly and Co. Capsules, EQ 250 mg and 500 mg base NDA 50-522 CECLOR (cefaclor) Oral Do. Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL NDA 50-527 DURICEF (cefadroxil) Oral Warner Chilcott, Inc., Suspension, EQ 125 mg Rockaway 80 Corporate base/5 mL Center, 100 Enterprise Dr., suite 280,Rockaway, NJ 07866 ANDA 61-229 POLYSPORIN (bacitracin Monarch Pharmaceuticals, zinc; polymyxin B Inc. sulfate) Ophthalmic Ointment, 500 units/g; 10,000 units/g

FDA has reviewed its records and, under [Section] 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

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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: September 24, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

[FR Doc. E8-23035 Filed 9-30-08; 8:45 am]

BILLING CODE 4160-01-S

Vol. 73, No. 191

[Docket No. FDA-2008-N-0506]

Notices

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