Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 28 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of March 16, 2020.
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FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, Martha.Nguyen@fda.hhs.gov.
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The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described 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 application or abbreviated application under § 314.150(c) is without prejudice to refiling.
|ANDA 040732||Phenytoin Sodium Capsules, 100 milligrams (mg) (Extended)||Wockhardt Limited, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053.|
|ANDA 065230||Ceftriaxone for Injection, Equivalent to (EQ) 250 mg base/vial; EQ 500 mg base/vial; EQ 1 gram (g) base/vial; EQ 2 g base/vial||Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.|
|ANDA 065231||Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vial Piggy Back||Do.|
|ANDA 065290||Cefotaxime Sodium for Injection, EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 065292||Cefotaxime Sodium for Injection, EQ 10 g base/vial Pharmacy Bulk Package||Do.|
|ANDA 065293||Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 065312||Cefoxitin for Injection, EQ 10 g base/vial Pharmacy Bulk Package||Do.|
|ANDA 065313||Cefoxitin for Injection, EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 065369||Cefepime Hydrochloride (HCl) for Injection, EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 065483||Cefuroxime Sodium for Injection, EQ 750 mg base/vial; EQ 1.5 g base/vial||Do.|
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|ANDA 065484||Cefuroxime Sodium for Injection, EQ 7.5 g base/vial Pharmacy Bulk Package||Do.|
|ANDA 065503||Cefuroxime Sodium for Injection, EQ 1.5 g base/vial||Do.|
|ANDA 075250||Prednisolone Sodium Phosphate Oral Solution, EQ 15 mg base/5 milliliters (mL)||Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.|
|ANDA 075618||Acetaminophen, Butalbital, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mg||Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.|
|ANDA 090375||Ampicillin and Sulbactam for Injection, EQ 1 g base/vial and EQ 500 mg base/vial; EQ 2 g base/vial and EQ 1 g base/vial||Hospira, Inc.|
|ANDA 090646||Ampicillin and Sulbactam for Injection, EQ 10 g base/vial and EQ 5 g base/vial||Do.|
|ANDA 090653||Ampicillin and Sulbactam for Injection, EQ 1 g base/vial and EQ 500 mg base/vial; EQ 2 g base/vial and EQ 1 g base/vial||Do.|
|ANDA 090825||Imipenem and Cilastatin for Injection, EQ 250 mg base/vial and 250 mg base/vial; EQ 500 mg base/vial and 500 mg/vial||Do.|
|ANDA 090940||Meropenem for Injection, 500 mg/vial, and 1 g/vial||Do.|
|ANDA 091007||Imipenem and Cilastatin for Injection, EQ 500 mg base/vial and 500 mg/vial||Do.|
|ANDA 202268||Cefepime HCl for Injection, EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 202563||Ceftriaxone for Injection, EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 202864||Ampicillin Sodium for Injection, EQ 250 mg base/vial; EQ 500 mg base/vial; EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 202865||Ampicillin Sodium for Injection, EQ 10 g base/vial Pharmacy Bulk Package||Do.|
|ANDA 203132||Cefotaxime Sodium for Injection, EQ 1 g base/vial; EQ 2 g base/vial||Do.|
|ANDA 204879||Pyridoxine HCl Injection, 100 mg/mL||Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford, IL 61103.|
|ANDA 206062||Doxorubicin HCl for Injection, USP, 20 mg/vial||Hisun Pharmaceutical Hangzhou Co., LTD, 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807.|
|ANDA 206195||Daunorubicin HCl for Injection, EQ 20 mg base/vial||Do.|
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 16, 2020. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. 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 the table that are in inventory on March 16, 2020 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.
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Dated: February 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03025 Filed 2-13-20; 8:45 am]
BILLING CODE 4164-01-P