AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of June 21, 2022.
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 .
SUPPLEMENTARY INFORMATION:
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.
| Application No. | Drug | Applicant |
|---|---|---|
| ANDA 040140 | Diphenhydramine Hydrochloride (HCl) Injection, 50 milligrams (mg)/milliliters (mL) | Hospira, Inc., 275 North Field Dr., Building H1-3S, Lake Forest, IL 60045. |
| ANDA 040578 | Benzphetamine HCl Tablets, 50 mg | ScinoPharm Taiwan, Ltd., 909 N Ford Ave., Fullerton, CA 92832. |
| ANDA 065267 | Cefprozil Tablets, 250 mg, and 500 mg | Bionpharma Inc., 600 Alexander Rd., Suite 2-4B, Princeton, NJ 08540. |
| ANDA 065284 | Cefprozil Oral Suspension, 125 mg/5 mL and 250 mg/5 mL | Do. |
| ANDA 065301 | Cefadroxil Tablets, Equivalent to (EQ) 1 gram (g) base | Do. |
| ANDA 065307 | Cefadroxil Oral Suspension, EQ 250 mg base/5 mL and EQ 500 mg base/5 mL | Do. |
| ANDA 065309 | Cefadroxil Capsules, EQ 500 mg base | Do. |
| ANDA 065326 | Cephalexin Oral Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL | Do. |
| ANDA 076720 | Morphine Sulfate Extended Release Tablets, 30 mg, and 60 mg | Nesher Pharmaceuticals (USA) LLC., 13910 Saint Charles Rock Rd., Bridgeton, MO 63044. |
| ANDA 076733 | Morphine Sulfate Extended Release Tablets, 15 mg | Do. |
| ANDA 077855 | Morphine Sulfate Extended Release Tablets, 100 mg and 200 mg | Do. |
| ANDA 080225 | Potassium Chloride Injection, 2 milliequivalent (mEq)/mL and 3 mEq/mL | Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. |
| ANDA 202393 | Diclofenac Sodium Topical Solution, 1.5% | TWi Pharmaceuticals, Inc., 536 Vanguard Way, Brea, CA 92821. |
| ANDA 203581 | Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg | Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke Pines, FL 33027. |
| ANDA 204137 | Omeprazole and Sodium Bicarbonate Capsules, 20 mg; 1.1 g | Unicorn Pharmaceuticals, 5 Links Circle, Durham, NC 27707. |
| ANDA 206588 | Dextroamphetamine Sulfate Tablets, 5 mg, and 10 mg | Nesher Pharmaceuticals (USA) LLC. |
| ANDA 208263 | Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100 mg base | Do. |
| ANDA 209111 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 10 mg, and 15 mg | Do. |
| ANDA 210079 | Oxycodone and Acetaminophen Tablets, 325 mg; 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg | Do. |
| ANDA 210080 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended Release Capsules, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg, 6.25 mg; 6.25 mg; 6.25 mg; 6.25 mg, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg | Do. |
| ANDA 211543 | Butalbital, Acetaminophen, and Caffeine Tablets, 325 mg; 50 mg; 40 mg | Do. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 21, 2022. 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 June 21, 2022, 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: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10924 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P