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Determination That DRIXORAL (Dexbrompheniramine Maleate; Pseudoephedrine Sulfate) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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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Amy Hopkins, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6223, Silver Spring, MD 20993-0002, 301-796-5418,

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In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 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 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic 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 removed 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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily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 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.

Application No.DrugApplicant
NDA 013483DRIXORAL (dexbrompheniramine maleate and pseudoephedrine sulfate) Tablet, Extended Release; Oral, 6 milligrams (mg)/120 mgMSD Consumer Care Inc., 556 Morris Ave., Summit, NJ 07901.
NDA 014685AVENTYL (nortriptyline hydrochloride (HCl)) Solution; Oral, Equivalent to (EQ) 10 mg Base/5mLRanbaxy Pharmaceuticals Inc., 600 College Rd. East, Princeton, NJ 08540.
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NDA 016418INDERAL (propranolol HCl) Tablet; Oral, 80 mgWyeth Pharmaceuticals Inc., C/O Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 016909LIDEX (fluocinonide) Ointment; Topical 0.05%County Line Pharmaceuticals, LLC, 13890 Bishop's Dr., Suite 410, Brookfield, WI 53005.
NDA 017373LIDEX (fluocinonide) Gel; Topical 0.05%.....Do.
NDA 020073ROMAZICON (flumazenil) Injectable; Injection, 1 mg/10 milliliters (mL) (0.1 mg/mL); 0.5 mg/5 mL (0.1 mg/mL)Hoffmann-La Roche Inc., C/O Genentech Inc., 1 DNA Way, South San Francisco, CA 94080-4990.
NDA 020229LEUSTATIN (cladribine) Injectable; Injection, 1 mg/mLJanssen Pharmaceuticals Inc., C/O Johnson and Johnson Pharmaceutical Research and Development LLC, 920 Rt. 202 South, P.O. Box 300, Raritan, NJ 08869.
NDA 020347HYTRIN (terazosin HCl) Capsule; Oral, EQ 1 mg Base; EQ 2 mg Base; EQ 5 mg Base; EQ 10 mg BaseAbbott Laboratories Pharmaceutical Products Division, Dept. 491 AP6B 1, Abbott Park, IL 60064.
NDA 020560FOSAMAX (alendronate sodium) Tablet; Oral, EQ 5 mg Base; EQ 10 mg Base; EQ 35 mg Base; EQ 40 mg BaseMerck and Co. Inc., 126 East Lincoln Ave., RY 33 212, P.O. Box 2000, Rahway, NJ 07065-0900.
NDA 020813KLONOPIN (clonazepam) Tablet, Orally Disintegrating Tablet (ODT); Oral, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, 2 mgHoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110.
NDA 021046CELEXA (citalopram hydrobromide) Solution; Oral, EQ 10 mg Base/5 mLForest Laboratories Inc., Harborside Financial Center, Plaza V, Suite 1900, Jersey City, NJ 07311.
NDA 022246METOZOLV ODT (metoclopramide HCl) Tablet, ODT; Oral, EQ 10 mg BaseSalix Pharmaceuticals Inc., 8510 Colonnade Center Dr., Raleigh, NC 27615.
NDA 050533VIBRA-TABS (doxycycline hyclate) Tablet; Oral, EQ 100 mg BasePfizer Laboratories Inc., 235 East 42nd St., New York, NY 10017.

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: August 8, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-19272 Filed 8-13-14; 8:45 am]