82 FR 182 pgs. 44185-44187 - Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
Type: NOTICEVolume: 82Number: 182Pages: 44185 - 44187
Pages: 44185, 44186, 44187Docket number: [Docket No. FDA-2017-N-5526]
FR document: [FR Doc. 2017-20107 Filed 9-20-17; 8:45 a.m.]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5526]
Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Applied Date: October 23, 2017.
[top]
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.
SUPPLEMENTARY INFORMATION:
The holders of the applications listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in §?314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an abbreviated application under §?314.150(c) is without prejudice to refiling.
[top]
| Application No. | Drug | Applicant |
|---|---|---|
| ANDA 061071 | Tetracycline Hydrochloride (HCl) Tablets, 250 milligrams (mg) | Department of Health and Human Services, Supply Service Center, PSC Bldg. 14 Boiler House Rd., Perry Point, MD 21902. |
| ANDA 062279 | Grifulvin V (griseofulvin microsize) Tablets USP,125 mg, 250 mg, and 500 mg | Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 062398 | Cephalexin Capsules, 250 mg and 500 mg | Department of Health and Human Services, Supply Service Center, PSC Bldg. 14 Boiler House Rd., Perry Point, MD 21902. |
| ANDA 062756 | Primaxin (cilastatin sodium and imipenem) for Injection, Equivalent to (EQ) 250 mg base/vial; 250 mg/vial and EQ 500 mg base/vial; 500 mg/vial | Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. |
| ANDA 062814 | Gentamicin Sulfate in 0.9% Sodium Chloride Injection, EQ 0.8 mg base/milliliter (mL), EQ 1.2 mg base/mL, EQ 1.4 mg base/mL, EQ 1.6 mg base/mL, EQ 1.8 mg base/mL, EQ 2 mg base/mL, EQ 2.4 mg base/mL, EQ 40 mg base/100 mL, EQ 60 mg base/100 mL, EQ 70 mg base/100 mL, EQ 80 mg base/100 mL, EQ 90 mg base/100 mL, EQ 100 mg base/100 mL, and EQ 120 mg base/100 mL | B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109. |
| ANDA 063239 | Rocephin (ceftriaxone sodium) for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, and EQ 1 gram (g) base/vial | Hoffmann-La Roche, Inc., c/o Genentech Inc., 1 DNA Way, MS 241B, South San Francisco, CA 94080. |
| ANDA 064127 | Erythromycin Topical Solution, 2% | Renaissance Pharma, Inc., 411 South State St., Suite E-100, Newton, PA 18940. |
| ANDA 064146 | Amikacin Sulfate in Sodium Chloride 0.9% Injection, EQ 500 mg base/100 mL | Hospira, Inc., Subsidiary of Pfizer Inc., 375 N. Field Dr., Lake Forest, IL 60045. |
| ANDA 070598 | Metoclopramide HCl Tablets, EQ 10 mg base | Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc. |
| ANDA 072080 | Furosemide Injection USP, 10 mg/mL | Hospira, Inc., Subsidiary of Pfizer Inc. |
| ANDA 074601 | Dipyridamole Injection, 5 mg/mL | Do. |
| ANDA 074720 | Acyclovir Sodium Injection, EQ 25 mg base/mL | Do. |
| ANDA 076564 | Adenosine Injection USP, 3 mg/mL | Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 078211 | Quinapril HCl and Hydrochlorothiazide Tablets, EQ 10 mg base/12.5 mg, EQ 20 mg base/12.5 mg, and EQ 20 mg base/25 mg | Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. |
| ANDA 078935 | Tramadol HCl Tablets USP, 50 mg | Northstar Healthcare Holdings, c/o Quality Regulatory Consultants, 1966 Anglers Cove, Vero Beach, FL 32963. |
| ANDA 080810 | Halothane USP, 99.99% | Halocarbon Products Corp., 1100 Dittman Ct., North Augusta, SC 29841. |
| ANDA 085458 | Dexamethasone Tablets USP, 0.5 mg | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 085883 | Acetaminophen and Codeine Phosphate Oral Suspension USP, 120 mg/5 mL and 12 mg/5 mL | Actavis Mid Atlantic LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 085884 | Cortisone Acetate Tablets USP, 25 mg | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. |
| ANDA 086179 | Carisoprodol Tablets USP, 350 mg | Do. |
| ANDA 086440 | Atropine Sulfate and Diphenoxylate HCl Capsules, 0.025 mg/2.5 mg | Catalent Pharma Solutions, Inc., 2725 Scherer Dr. North, St. Petersburg, FL 33716. |
| ANDA 087535 | Methylprednisolone Sodium Succinate for Injection USP, EQ 500 mg base/vial and EQ 1 g base/vial | Organon USA, Inc., Subsidiary of Merck and Co., Inc., 126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ 07065. |
| ANDA 087711 | Dexamethasone Acetate Injectable Suspension USP, EQ 16 mg base/mL | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. |
| ANDA 088346 | Heparin Lock Flush Solution USP and 0.9% Sodium Chloride Injection USP, 10 USP heparin units/mL and 100 USP heparin units/mL | Hospira, Inc. |
| ANDA 088852 | Chlorpropamide Tablets USP, 100 mg | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. |
| ANDA 091201 | Meropenem for Injection USP, 500 mg/vial and 1 g/vial | Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. |
| ANDA 200156 | Armodafinil Tablets, 100 mg and 200 mg | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. |
Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn, effective October 23, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20107 Filed 9-20-17; 8:45 a.m.]
BILLING CODE 4164-01-P