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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of January 2, 2020.
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) (21CFR 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 040759 | Phenytoin Sodium Capsules, 30milligrams (mg) (Extended) | Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053. |
| ANDA 062349 | Nystatin Oral Suspension, 100,000 units/milliters (mL) | G&W Laboratories, Inc., 301 Helen St., South Plainfield, NJ 07080. |
| ANDA 062483 | Griseofulvin V (griseofulvin microsize) Oral Suspension, 125 mg/5 mL | Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 063264 | Amikacin Sulfate Injection USP, Equivalent to (EQ) 250 mg base/mL | Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. |
| ANDA 072655 | Amantadine Hydrochloride (HCl) Syrup USP, 50 mg/5 mL | G&W Laboratories, Inc. |
| ANDA 074176 | Cimetidine HCl Oral Solution, EQ 300 mg base/5 mL | Do. |
| ANDA 075366 | Sotalol HCl Tablets USP 80 mg, 120 mg, 160 mg, and 240 mg | Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. |
| ANDA 075887 | Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg | Do. |
| ANDA 076709 | Fentanyl Extended-Release Film, 25 micrograms (mcg)/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr | Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc, 577 Chipeta Way, Salt Lake City, UT 84108. |
| ANDA 076841 | Mesalamine Enema, 4 grams (gm)/60 mL | G&W Laboratories, Inc. |
| ANDA 077062 | Fentanyl Extended-Release Film, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr | Mayne Pharma LLC, 1240 Sugg Parkway, Greenville, NC 27834. |
| ANDA 078426 | Zolpidem Tartrate Tablets, 5 mg and 10 mg | Morton Grove Pharmaceuticals Inc. |
| ANDA 078653 | Ranitidine HCl Tablets USP, EQ 150 mg base | Do. |
| ANDA 078701 | Ranitidine HCl Tablets USP, EQ 150 mg base and EQ 300 mg base | Do. |
| ANDA 078884 | Ranitidine HCl Tablets USP, EQ 75 mg base | Do. |
| ANDA 087811 | Phrenilin (acetaminophen and butalbital) Tablets, 325 mg/50 mg | Bausch Health US, LLC. |
| ANDA 088761 | Prometh VC Plain (promethazine HCl and phenylephrine HCl) Syrup, 5 mg/5mL, and 6.25 mg/5 mL | G&W Laboratories, Inc. |
| ANDA 088762 | Prometh w/Dextromethorphan (promethazine HCl and dextromethorphan hydrobromide) Syrup, 6.25 mg/5 mL and 15 mg/5 mL | Do. |
| ANDA 090786 | Carbidopa, Entacapone, and Levodopa Tablets, 12.5 mg/200 mg/50 mg | Morton Grove Pharmaceuticals Inc. |
| ANDA 091267 | Donepezil HCl Tablets, 5 mg and 10 mg | Do. |
| ANDA 201947 | Morphine Sulfate Oral Solution, 10 mg/5 mL and 20 mg/5 mL | VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771. |
| Do = Ditto. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of January 2, 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 January 2, 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.
Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25946 Filed 11-29-19; 8:45 am]
BILLING CODE 4164-01-P