AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of December 1, 2021.
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.
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.
| Application No. | Drug | Applicant |
|---|---|---|
| NDA 007409 | Bentyl (dicyclomine hydrochloride (HCl)) Capsules, 10 milligram (mg) | Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940. |
| Bentyl (dicyclomine HCl) Tablets, 20 mg | ||
| NDA 013625 | Norinyl 1 + 50 (norethindrone and mestranol) Tablets, 0.05 mg/1 mg Norinyl (norethindrone and mestranol) Tablets, 0.1 mg/2 mg | Actavis Laboratories UT, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 145 Brandywine Pkwy., West Chester, PA 19380. |
| NDA 014169 | Dendrid (idoxuridine) Ophthalmic Solution, 0.1% | Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134. |
| NDA 019404 | Ocufen (flurbiprofen sodium) Ophthalmic Solution, 0.03% | Allergan, Inc., 2525 Dupont Dr., Irvine, CA 92612. |
| NDA 019784 | Ibuprofen Oral Suspension, 100 mg/5 milliliters (mL) | Abbott Laboratories Established Pharmaceuticals Products Division, 200 Abbott Park Rd., Abbott Park, IL 60064. |
| NDA 020010 | Lotrisone (betamethasone dipropionate and clotrimazole) Lotion, Equivalent to (EQ) 0.05% base/1% | Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889. |
| NDA 020098 | Mivacron (mivacurium chloride) Solution, EQ 2 mg base/mL, EQ 10 mg base/5 mL, and EQ 20 mg base/10 mL | AbbVie, Inc., 1 N Waukegan Rd., North Chicago, IL 60064 |
| Mivacron in Dextrose 5% in plastic container (mivacurium chloride) Injectable, EQ 0.5 mg base/mL and EQ 50 mg base/100 mL | ||
| NDA 020412 | Zerit (stavudine) Capsules, 5 mg, 15 mg, 20 mg, 30 mg, and 40 mg | Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543. |
| NDA 020509 | Gemzar (gemcitabine HCl) Injection, EQ 200 mg base and EQ 1 gram (g) base | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 020696 | Antizol (fomepizole) Injection, 1.5 g/1.5 mL | Par Sterile Products, LLC, 6 Ram Ridge Rd., Chestnut Ridge, NY 10977. |
| NDA 020705 | Rescriptor (delavirdine mesylate) Tablets, 100 mg and 200 mg | ViiV Healthcare Co., 5 Moore Dr., Research Triangle Park, NC 27709. |
| NDA 021114 | Betaxon (levobetaxolol HCl) Ophthalmic Suspension, EQ 0.5% base | Alcon Laboratories, Inc. |
| NDA 021199 | Quixin (levofloxacin) Ophthalmic Solution, 0.5% | Santen Inc., 6401 Hollis St., Suite 125, Emeryville, CA 94608. |
| NDA 021571 | Iquix (levofloxacin) Ophthalmic Solution, 1.5% | Do. |
| NDA 050704 | DaunoXome (daunorubicin citrate liposome injection), EQ 2 mg base/mL | Galen Limited, 25 Fretz Rd., Souderton, PA 18964. |
| NDA 204736 | AcipHex Sprinkle (rabeprazole sodium) Delayed Release Capsules, 5 mg and 10 mg | Aytu BioScience Inc., 373 Inverness Parkway, Suite 206, Englewood, CO 80112. |
| NDA 205060 | Epanova (omega-3-carboxylic acids) Capsules, 1 gram (1 g contains at least 850 mg of polyunsaturated fatty acids) | AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803. |
| NDA 206843 | Daklinza (daclatasvir dihydrochloride) Tablets, EQ 30 mg base, EQ 60 mg base, and EQ 90 mg base | Bristol-Myers Squibb Co. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 1, 2021. 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 December 1, 2021 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: October 25, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23729 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P