87 FR 146 pgs. 46962-46963 - Lupin Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
Type: NOTICEVolume: 87Number: 146Pages: 46962 - 46963
Pages: 46962, 46963Docket number: [Docket No. FDA-2022-N-1528]
FR document: [FR Doc. 2022-16383 Filed 7-29-22; 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-1528]
Lupin Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of August 31, 2022.
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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 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 065125 | Ceftriaxone for Injection, Equivalent to (EQ) 250 milligrams (mg) base/vial; EQ 500 mg base/vial; EQ 1 gram (g) base/vial; EQ 2 g base/vial | Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. |
| ANDA 078188 | Irinotecan Hydrochloride Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 mg/5 mL (20 mg/mL) | Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. |
| ANDA 090088 | Anastrozole Tablets, 1 mg | Do. |
| ANDA 206002 | Bosentan Tablets, 62.5 mg and 125 mg | Alvogen Pine Brook, LLC, 44 Whippany Rd., Suite 300, Morristown, NJ 07960. |
| ANDA 212185 | Chlorzoxazone Tablets, 375 mg and 750 mg | Glenmark Pharmaceuticals Inc., USA, 750 Corporate Dr., Mahwah, NJ 07430. |
| ANDA 212186 | Amphetamine Sulfate Tablets, 5 mg and 10 mg | Do. |
| ANDA 213132 | Arformoterol Tartrate Inhalation Solution, EQ 0.015 mg base/2 mL | Do. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 31, 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 August 31, 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: July 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16383 Filed 7-29-22; 8:45 am]
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