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Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.



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The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. 6207, 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 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 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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 011522ADDERALL (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate) Tablet; Oral, 5 milligrams (mg), 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, 30 mgTeva Womens Health Inc., 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355.
NDA 011601KENALOG (triamcinolone acetonide) Cream; Topical, 0.025%, 0.1%Apothecon Pharmaceuticals, General Offices, P.O. Box 4500, Princeton, NJ 08543-4500.
NDA 013601MUCOMYST (acetylcysteine) Solution; Inhalation, Oral, 10%, 20%Do.
NDA 018531NITROGLYCERIN (nitroglycerin) Injectable; Injection, 5mg/milliliter (mL)Hospira Inc., 275 North Field Dr., Bldg. H2, Lake Forest, IL 60045-5046.
NDA 018726WESTCORT (hydrocortisone valerate) Ointment; Topical, 0.2%Ranbaxy Inc., 600 College Rd., East Princeton, NJ 08540.
NDA 018830TAMBOCOR (flecainide acetate) Tablet; Oral, 50 mg, 100 mg, 150 mgMedicis Pharmaceutical Corp., 7720 North Dobson Rd., Scottsdale, AZ 85256.
NDA 020336DYNACIRC CR (isradipine) Tablet; Extended Release, Oral, 5 mg, 10 mgGlaxoSmithKline LLC., 2711 Centerville Rd., Ste. 400, Wilmington, DE 19808.
NDA 020518RETROVIR (zidovudine) Tablet; Oral, 300 mgViiV Healthcare, 5 Moore Dr., Research Triangle Park, NC 27709.
NDA 021745RYZOLT (tramadol HCl) Tablet; Extended Release, Oral, 100 mg, 200 mg, 300 mgPurdue Pharma Products LP, 1 Stamford Forum, Stamford, CT 06901.
NDA 022021ALTACE (ramipril) Tablet; Oral, 1.25 mg, 2.5 mg, 5 mg, 10 mgPfizer Inc., 501 5th St., Bristol, TN 37620.
NDA 050808SOLODYN (minocycline HCl) Tablet; Extended Release; Equivalent to (EQ) 45 mg Base, EQ 90 mg Base, EQ 135 mg BaseMedicis Pharmaceutical Corp., 7720 North Dobson Rd., Scottsdale, AZ 85256.
ANDA 081295ESTRACE (estradiol) Tablet; Oral, 0.5 mgBristol Myers Squibb, P.O. Box 4000, Princeton, NJ 08543.
ANDA 084499ESTRACE (estradiol) Tablet; Oral, 1 mgDo.
ANDA 084500ESTRACE (estradiol) Tablet; Oral, 2 mgDo.

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 and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. 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: November 5, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-26856 Filed 11-8-13; 8:45 am]