87 FR 22 pgs. 5827-5828 - Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications
Type: NOTICEVolume: 87Number: 22Pages: 5827 - 5828
Pages: 5827, 5828Docket number: [Docket No. FDA-2022-N-0079]
FR document: [FR Doc. 2022-02059 Filed 2-1-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0079]
Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of March 4, 2022.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137, Kimberly.Lehrfeld@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 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.
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| Application No. | Drug | Applicant |
|---|---|---|
| NDA 006134 | Dolophine (methadone hydrochloride (HCl)) Tablets, 5 milligrams (mg), and 10 mg | Hikma Pharmaceuticals USA, Inc., 1809 Wilson Rd., Columbus, OH 43228. |
| Dolophine (methadone HCl) Syrup, 10 mg/30 milliliter (mL) | ||
| NDA 006882 | Phisohex (hexachlorophene) Emulsion, 3% | Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 009818 | Kemadrin (procyclidine HCl) Tablets, 2 mg, and 5 mg | Monarch Pharmaceuticals, LLC, c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 012301 | Librium (chlordiazepoxide HCl), Injection, 100 mg/ampule | Bausch Health US, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| NDA 013416 | Norgesic (orphenadrine citrate, aspirin, and caffeine) Tablets, 25 mg/385 mg/30 mg | Bausch Health US, LLC. |
| Norgesic Forte (orphenadrine citrate, aspirin, and caffeine) Tablets, 50 mg/770 mg/60 mg | ||
| NDA 014228 | Spandin (aspirin and sodium salicylate) Time-released Tablets, 7.5 grains/2.5 grains | Abbott Healthcare Pvt. Ltd., c/o G&L Scientific, Independence Blvd., 4th Floor, Warren, NJ 07059. |
| NDA 016194 | Talwin (pentazocine lactate) Injection, equivalent to (EQ) 30 mg base/mL | Hospira Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. |
| NDA 016418 | Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 90 mg | Wyeth Pharmaceuticals LLC, 235 E. 42nd St., New York, NY 10017. |
| NDA 016704 | Resectisol (mannitol) Irrigation Solution, 5 grams (g)/100 mL | B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109. |
| NDA 016762 | Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg | Wyeth Pharmaceuticals LLC. |
| NDA 016954 | Micronor (norethindrone) Tablets, 0.35 mg | Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. |
| NDA 017013 | Sodium Chloride Injection, 20 g/100 mL | Abbott Healthcare Pvt. Ltd., c/o G&L Scientific. |
| NDA 017683 | Inderal (propranolol HCL) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg | Wyeth Pharmaceuticals LLC. |
| NDA 018423 | Hibiclens (chlorhexidine gluconate) Sponge, 4% | Mölnlycke Health Care, 5445 Triangle Pkwy., Suite 400, Peachtree Corners, GA 30092. |
| NDA 018703 | Zantac (ranitidine HCl) Tablets, EQ 150 mg base, and EQ 300 mg base | GlaxoSmithKline Intellectual Property Ltd. England, c/o GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA 19112. |
| NDA 019387 | Profenal (suprofen) Ophthalmic Solution, 1% | Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134-2099. |
| NDA 019530 | Ucephan (sodium benzoate and sodium phenylacetate) Solution, 100 mg/mL; 100 mg/mL | B. Braun Medical Inc. |
| NDA 019675 | Zantac (ranitidine HCl) Syrup, EQ 15 mg base/mL | GlaxoSmithKline Intellectual Property Ltd. England, c/o GlaxoSmithKline. |
| NDA 019814 | Betagan (levobunolol HCl) Ophthalmic Solution, 0.25% | Allergan, Inc. |
| NDA 019927 | Nizoral (ketoconazole) Shampoo, 2% | Janssen Pharmaceuticals, Inc. |
| NDA 020037 | Voltaren (diclofenac sodium) Ophthalmic Solution, 0.1% | Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936-1080. |
| NDA 021169 | Razadyne (galantamine hydrobromide) Tablets, EQ 4 mg base, EQ 8 mg base, and EQ 12 mg base | Janssen Research & Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560. |
| NDA 021204 | Starlix (nateglinide) Tablets, 60 mg, and 120 mg | Novartis Pharmaceuticals Corp. |
| NDA 021406 | Fortical (calcitonin-salmon recombinant) Nasal Spray, 200 International Units/Spray | Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. |
| NDA 021860 | Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ 15 mg base, and EQ 20 mg base | Allergan Pharmaceuticals International Ltd., c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940. |
| NDA 202833 | Picato (ingenol mebutate) Gel, 0.015%, and 0.05% | LEO Laboratories Ltd., c/o LEO Pharma Inc., 7 Giralda Farms, Madison, NJ 07940. |
| NDA 202880 | Zohydro ER (hydrocodone bitartrate) Extended-release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | Recro Gainesville LLC, 1300 Gould Dr., Gainesville, GA 30504. |
| NDA 204683 | Khedezla (desvenlafaxine) Extended-Release Tablets, 50 mg, and 100 mg | Osmotica Pharmaceutical US LLC, 400 Crossing Blvd., Bridgewater, NJ 08807. |
| NDA 207916 | Cetylev (acetylcysteine) Effervescent Tablets, 500 mg, and 2.5 g | Arbor Pharmaceuticals, LLC, 6 Concourse Pkwy., Suite 1800, Atlanta, GA 30328. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 4, 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 March 4, 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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02059 Filed 2-1-22; 8:45 am]
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