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Determination That DECADRON Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) has determined that the 10 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

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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.

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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 Under FDA regulations, a drug is withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the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 18-821 for REGLAN (metoclopramide) Oral Solution in the Federal Register of October 10, 2002 (67 FR 63107).)

Application No.DrugApplicant
NDA 11-664DECADRON (dexamethasone) Tablets, 0.5 milligram (mg) and 0.75 mgMerck & Co., P.O. Box 4, BLA-20, West Point, PA 19486
NDA 15-229AMICAR (aminocaproic acid) Injection, 250 mg/milliliter (mL)Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071-4563
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NDA 16-636NARCAN (naloxone hydrocholoride (HCl)) Injection, 0.02 mg/mL, 0.4 mg/mL, and 1 mg/mLEndo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford, PA 19317
NDA 16-929FUDR (floxuridine) Injection, 500 mg/vialHospira, Inc., 275 North Field Dr., Lake Forest, IL 60045
NDA 18-538LOZOL (indapamide) Tablets, 1.25 mg and 2.5 mgSanofi-Aventis U.S., 55 Corporate Blvd., P.O. Box 5925, Bridgewater, NJ 08807
NDA 18-821REGLAN (metaclopramide HCl) Oral Solution, equivalent to (EQ) 5 mg base/5 mLA.H. Robins Co., c/o Wyeth-Ayerst Research, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 18-831TRACRIUM (atracurium besylate) Injection, 10 mg/mLHospira, Inc.
NDA 18-831TRACRIUM (atracurium besylate) Preservative Free Injection, 10 mg/mLDo.
NDA 19-080PROSOM (estazolam) Tablets, 1 mg and 2 mgAbbott Laboratories, 200 Abbott Park Rd., D-491, AP30-1E, Abbott Park, IL 60064-6157
NDA 20-397ZANAFLEX (tizanidine HCL) Tablets, EQ 2 mg baseAcorda Therapeutics, 15 Skyline Dr., Hawthorne, NY 10532

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.

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Dated: May 6, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-11217 Filed 5-13-09; 8:45 am]