Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Approval is withdrawn as of July 27, 2020.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 060567||Lidocaine Hydrochloride (HCl); Oxytetracycline Injection, 2%; 50 milligrams (mg)/milliters (mL), and 2%; 125 mg/mL||Pfizer Inc., 235 East 42nd St., New York, NY 10017.|
|ANDA 062612||Gentamicin Sulfate Injection, Equivalent to (EQ) 10 mg base/mL||Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.|
|ANDA 062811||Clindamycin Phosphate Solution, EQ 1% base||G&W Laboratories Inc., 301 Helen St., South Plainfield, NJ 07080.|
|ANDA 063333||Cefoperazone Sodium for Injection, EQ 1 gram (gm) base/vial||Pfizer Inc.|
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|ANDA 078288||Ondansetron HCl Injection, EQ 2 mg base/mL||Baxter Healthcare Corp., 1 Baxter Parkway, Deerfield, IL 60015.|
|ANDA 080426||Hydrocortisone Lotion, 0.5%||Bausch Health Americas Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.|
|ANDA 090813||Levetiracetam Injection, 500 mg/5 mL (100 mg/mL)||Fresenius Kabi USA, LLC., Three Corporate Dr., Lake Zurich, IL 60047.|
|ANDA 201751||Articaine HCl; Epinephrine Bitartrate Injection, 4%; EQ 0.0085 mg base/1.7 mL; 4%; EQ 0.005 mg base/mL||Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323.|
|ANDA 202684||Levonorgestrel Tablets, 0.75 mg||Alvogen PB Research and Development LLC, U.S. Agent for Lotus Pharmaceutical Co., Ltd. Nantou Plant, 44 Whippany Rd., Suite 300, Morristown, NJ 07960.|
|ANDA 204796||Capreomycin Sulfate for Injection, EQ 1 gm base/vial||Hisun Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807.|
|ANDA 205943||Ethinyl Estradiol; Levonorgestrel Tablets, 0.02 mg, 0.15 mg; 0.025 mg, 0.15 mg; 0.03 mg, 0.15 mg; 0.01 mg, N/A||Lupin Pharmaceuticals, Inc., 111 South Calvert St., Baltimore, MD 21202.|
|ANDA 212191||Fluoxetine HCl Tablets, EQ 60 mg base||G&W Laboratories, Inc.|
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 27, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms 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 July 27, 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: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13661 Filed 6-24-20; 8:45 am]
BILLING CODE 4164-01-P