82 FR 178 pgs. 43388-43390 - Determination That CORTONE (Cortisone Acetate) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Type: NOTICEVolume: 82Number: 178Pages: 43388 - 43390
Pages: 43388, 43389, 43390Docket number: [Docket No. FDA-2017-N-4758]
FR document: [FR Doc. 2017-19611 Filed 9-14-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4758]
Determination That CORTONE (Cortisone Acetate) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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).
[top] 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
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 are no longer being marketed.
| Application No. | Drug name | Active ingredient(s) | Strength(s) | Dosage form/route | Applicant |
|---|---|---|---|---|---|
| NDA 007750 | CORTONE | Cortisone Acetate | 25 milligrams (mg) | Tablet; Oral | Merck & Co., Inc. |
| NDA 008662 | NYDRAZID | Isoniazid | 100 mg/milliliter (mL) | Injectable; Injection | Sandoz Canada Inc. |
| NDA 010571 | COMPAZINE | Prochlorperazine Maleate | Equivalent to (EQ) 5 mg Base; EQ 10 mg Base; EQ 25 mg Base | Tablet; Oral | SmithKline Beecham Corporation d/b/a GlaxoSmithKline. |
| NDA 010670 | ORINASE | Tolbutamide | 250 mg; 500 mg | Tablet; Oral | Pharmacia and Upjohn Co. |
| NDA 011127 | COMPAZINE | Prochlorperazine | 2.5 mg; 5 mg; 25 mg | Suppository; Rectal | SmithKline Beecham Corporation d/b/a GlaxoSmithKline. |
| NDA 011808 | MELLARIL | Thioridazine Hydrochloride (HCl) | 30 mg/mL; 100 mg/mL | Concentrate; Oral | Novartis Pharmaceuticals Corp. |
| NDA 012145 | PROLIXIN | Fluphenazine HCl | 2.5 mg/5 mL | Elixir; Oral | Apothecon Inc., Division of Bristol Myers Squibb. |
| NDA 014713 | ETRAFON 2-10; ETRAFON 2-25; ETRAFON-A; ETRAFON-FORTE | Perphenazine; Amitriptyline HCl | 2 mg/10 mg; 2 mg/25 mg; 4 mg/10 mg; 4 mg/25 mg | Tablet; Oral | Schering Corp. |
| NDA 014715 | TRIAVIL 2-10; TRIAVIL 2-25; TRIAVIL 4-10; TRIAVIL 4-25; TRIAVIL 4-50 | Perphenazine; Amitriptyline HCl | 2 mg/10 mg; 2 mg/25 mg; 4 mg/10 mg; 4 mg/25 mg; 4 mg/50 mg | Tablet; Oral | New River Pharmaceuticals Inc. |
| NDA 015539 | SERAX | Oxazepam | 10 mg; 15 mg; 30 mg; 15 mg | Capsule; Oral Tablet; Oral | Alpharma U.S. Pharmaceuticals Division. |
| NDA 015922 | HALDOL | Haloperidol Lactate | EQ 2 mg Base/mL | Concentrate; Oral | Ortho-McNeil Pharmaceutical. |
| NDA 016584 | NAVANE | Thiothixene | 1 mg; 2 mg; 5 mg; 10 mg; 20 mg | Capsule; Oral | Pfizer Inc. |
| NDA 016721 | DALMANE | Flurazepam HCl | 15 mg; 30 mg | Capsule; Oral | Valeant Pharmaceuticals International. |
| NDA 017923 | MELLARIL-S | Thioridazine | EQ 25 mg HCl/5 mL; EQ 100 mg HCl/5mL | Suspension; Oral | Novartis Pharmaceuticals Corp. |
| NDA 018374 | BACTRIM | Sulfamethoxazole; Trimethoprim | 80 mg/mL; 16 mg/mL | Injectable; Injection | Sun Pharmaceutical Industries, Inc. |
| NDA 018485 | ISOPTIN | Verapamil HCl | 2.5 mg/mL | Injectable; Injection | Mt. Adams Technologies LLC. |
| NDA 018596 | INTAL | Cromolyn Sodium | 10 mg/mL | Solution; Inhalation | King Pharmaceuticals LLC. |
| NDA 018644 | WELLBUTRIN | Bupropion HCl | 50 mg; 75 mg; 100 mg | Tablet; Oral | GlaxoSmithKline LLC. |
| NDA 019287 | DIZAC | Diazepam | 5 mg/mL | Injectable; Injection | Pharmacia and Upjohn Co. |
| NDA 019982 | ZEBETA | Bisoprolol Fumarate | 5 mg; 10 mg | Tablet; Oral | Teva Branded Pharmaceutical Products R&D, Inc. |
| NDA 020007 | ZOFRAN; ZOFRAN PRESERVATIVE FREE | Ondansetron HCl | EQ 2 mg Base/mL | Injectable; Injection | Novartis Pharmaceuticals Corp. |
| NDA 020205 | PSORCON | Diflorasone Diacetate | 0.05% | Cream; Topical | Taro Pharmaceuticals North America Inc. |
| NDA 020947 | PENNSAID | Diclofenac Sodium | 1.5% | Solution; Topical | Nuvo Pharmaceuticals Inc. |
| NDA 021575 | FOSAMAX | Alendronate Sodium | EQ 70 mg Base/75 mL | Solution; Oral | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
| NDA 050542 | AMOXIL | Amoxicillin | 125 mg; 250 mg | Chewable Tablet; Oral | Dr. Reddy's Laboratories, Inc. |
| NDA 050564 | AUGMENTIN '250'; AUGMENTIN '500' | Amoxicillin; Clavulanate Potassium | 250 mg/EQ 125 mg Base; 500 mg/EQ 125 mg Base | Tablet; Oral | Do. |
| NDA 050581 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER; MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | Cefoxitin Sodium | EQ 20 mg Base/mL; EQ 40 mg Base/mL; EQ 20 mg Base/mL; EQ 40 mg Base/mL | Injectable; Injection | Merck & Co., Inc. |
| NDA 050591 | BACTROBAN | Mupirocin | 2% | Ointment; Topical | SmithKline Beecham (Cork) Ltd., Ireland. |
| NDA 050594 | ERYCETTE | Erythromycin | 2% | Swab; Topical | Johnson & Johnson Consumer Inc. |
| NDA 050754 | AMOXIL | Amoxicillin | 500 mg; 875 mg | Tablet; Oral | Dr. Reddy's Laboratories, Inc. |
| NDA 050760 | AMOXIL | Amoxicillin | 200 mg/5 mL; 400 mg/5 mL | For Suspension; Oral | Do. |
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FDA has reviewed its records and, under §?314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products 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 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.
Dated: September 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19611 Filed 9-14-17; 8:45 am]
BILLING CODE 4164-01-P