88 FR 242 pg. 87787 - Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Type: NOTICEVolume: 88Number: 242Page: 87787
Page: 87787Docket number: [Docket No. FDA-2023-N-5431]
FR document: [FR Doc. 2023-27853 Filed 12-18-23; 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-2023-N-5431]
Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of January 18, 2024.
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 the 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 063081 | Tobramycin Sulfate, Injectable, Equivalent to (EQ) 1.2 milligrams (mg) base/milliliters (mL), EQ 1.6 mg base/mL, EQ 80 mg base/100 mL | Hospira, Inc., 275 North Field Dr., Building H1-3S, Lake Forest, IL 60045. |
| ANDA 063112 | Tobramycin Sulfate, Injection, EQ 10 mg base/mL | Do. |
| ANDA 078907 | Fentanyl Citrate, Troche/Lozenges, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg base, EQ 1.2 mg base, EQ 1.6 mg base | SpecGx LLC, 385 Marshall Ave., Webster Groves, MO 63119. |
| ANDA 080629 | Promethazine Hydrochloride (HCl), Injectable, 50 mg/mL | Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Building A, Parsippany, NJ 07054. |
| ANDA 091170 | Zoledronic Acid, Injectable, EQ 4 mg base/5 mL | Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 201, Berlin, CT 06037. |
| ANDA 201846 | Azelastine HCl, Metered Spray, 0.2055 mg/spray | Apotex Corp, U.S. Agent for Apotex Inc., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326. |
| ANDA 207698 | Nevirapine Extended-Release Tablets, 400 mg | Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo Pharma Limited, 279 Princeton-Hightstown Rd., East Windsor, NJ 08520. |
| ANDA 208616 | Nevirapine Extended-Release Tablets, 100 mg | Do. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of January 18, 2024. 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 listed in the table without an approved new drug application or ANDA 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 the table that are in inventory on January 18, 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: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27853 Filed 12-18-23; 8:45 am]
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