89 FR 107 pgs. 47566-47567 - Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
Type: NOTICEVolume: 89Number: 107Pages: 47566 - 47567
Pages: 47566, 47567Docket number: [Docket No. FDA-2024-N-2462]
FR document: [FR Doc. 2024-12065 Filed 5-31-24; 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-2024-N-2462]
Pfizer, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of July 3, 2024.
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 table 1 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 012427 | Didrex (benzfetamine hydrogen chloride (HCl)) Tablets, 25 milligrams (mg) and 50 mg | Pfizer, Inc., 66 Hudson Boulevard East, New York, NY 10001. |
| NDA 016131 | Clomid (clomiphene citrate) Tablets, 50 mg | Sanofi US Services Inc., C/O Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807. |
| NDA 016584 | Navane (thiothixene HCl) Capsules, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg | Do. |
| NDA 019032 | Tenex (guanfacine HCl) Tablets, 1 mg, 2 mg, and 3 mg | Promius Pharma, LLC, C/O Dr. Reddy's Laboratories Inc., 107 College Rd. East, Princeton, NJ 08540. |
| NDA 019776 | Concentraid (desmopressin acetate) Nasal Solution, 0.01% | Ferring Pharmaceuticals Inc., 100 Interpace Parkway, Parsippany, NJ 07054. |
| NDA 019826 | Theophylline and Dextrose 5% Injections in Plastic Container, 40 mg/100 milliliters (mL), 80 mg/100 mL, 160 mg/100 mL, 200 mg/100 mL, 320 mg/100 mL, and 400 mg/100 mL | B. Braun Medical Inc, 901 Marcon Blvd., Allentown, PA 18109. |
| NDA 020659 | Norvir (ritonavir) Oral Solution, 80 mg/mL | AbbVie Inc. 1 N. Waugekan Rd., North Chicago, IL 60064. |
| NDA 020706 | Emadine (emedastine difumarate) Ophthalmic Solution, 0.05% | Novartis Pharmaceuticals Co., 1 Health Plaza, East Hanover, NJ 07936-1080 |
| NDA 020884 | Aggrenox (aspirin and dipyridamole) Extended-Release Capsules, 25 mg/200 mg | Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd, Ridgefield, CT 06877. |
| NDA 020928 | Glucagon Injection, 1 mg/vial | Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 020972 | Sustiva (efavirenz) Capsules, 50 mg, 100 mg, and 200 mg | Bristol-Myers Squibb Company, P.O. Box 4000, Princeton, NJ 08543-4000. |
| NDA 021400 | Levitra (vardenafil HCI) Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg | Bayer HealthCare Pharmaceuticals Inc. |
| NDA 021449 | Hepsera (adefovir dipivoxil) Tablets, 10 mg | Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404. |
| NDA 021623 | Synera (lidocaine and tetracaine) Patch, 70 mg/70 mg | Galen Specialty Pharma US, LLC, 25 Fretz Rd., Souderton, PA 18694. |
| NDA 022331 | Kapvay (clonidine HCl) Extended-Release Tablets, 0.1 mg and 0.2 mg Jenloga (clonidine HCl) Extended-Release Tablets, 0.1 mg and 0.2 mg | Concordia Pharmaceuticals, Inc C/O Cardinal Health Reg Sciences, 7400 West 110th St., Suite 150, Overland Park, KS 66210. |
| NDA 022343 | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg | Aurobindo Pharma Limited C/O Aurobindo Pharma USA, Inc., 279 Princeton-Highstown Rd., East Windsor, NJ 08520. |
| NDA 022344 | Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 300 mg/300 mg | Do. |
| NDA 200179 | Staxyn (vardenafil HCl) Orally Disintegrating Tablets, 10 mg | Bayer HealthCare Pharmaceuticals, Inc. |
| NDA 200671 | Durlaza (aspirin) Extended-Release Capsules, 162.5 mg | HESP LLC, 312 Farmington Ave., Farmington, CT 06032. |
| NDA 202158 | Radiogenix System (technetium Tc-99m generator) For the Production of Sodium Pertechnetate Tc 99m Injection, Intravenous, Intravesicular, and Ophthalmic Solution, 30-1153 millicurie/Generator | NorthStar Medical Radioisotopes, LLC, 1800 Gateway Blvd., Beloit, WI 53511. |
| NDA 205004 | Bortezomib Powder for Injection, 3.5 mg/vial | Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL 60047. |
| NDA 205787 | Evzio (naloxone HCl) Solution for Injection, 0.4 mg/0.4 mL | Kaleo, Inc., 111 Virginia St., Suite 300, Richmond, VA 23219. |
| NDA 209862 | Evzio (naloxone HCl) Auto-Injector for Injection, 2 mg/0.4 mL | Do. |
Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of July 3, 2024. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on July 3, 2024 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 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12065 Filed 5-31-24; 8:45 am]
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