88 FR 191 pgs. 68628-68629 - Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
Type: NOTICEVolume: 88Number: 191Pages: 68628 - 68629
Pages: 68628, 68629Docket number: [Docket No. FDA-2023-N-3859]
FR document: [FR Doc. 2023-21992 Filed 10-3-23; 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-3859]
Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 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 11 abbreviated new drug applications (ANDAs) from Dr. Reddy's Laboratories, Inc. The applicant 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of November 3, 2023.
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:
[top] The applicant listed in the table has informed FDA that these drug products are no longer marketed and has requested that FDA withdraw approval of the applications under the process described in §?314.150(c) (21 CFR 314.150(c)). The applicant has also, by their request, 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 090177 | Oxycodone and Acetaminophen Tablets, 3.25 milligrams (mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg, 500 mg; 7.5 mg, 650 mg; 10 mg | Dr. Reddy's Laboratories, Inc., U.S. Agent for Dr. Reddy's Laboratories SA, 107 College Rd. East, Princeton NJ 08540. |
| ANDA 091313 | Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg | Do. |
| ANDA 091670 | Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mg | Do. |
| ANDA 203107 | Oxycodone HCl Capsules, 5 mg | Do. |
| ANDA 203335 | Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mg | Do. |
| ANDA 203807 | Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mg | Do. |
| ANDA 204092 | Oxycodone HCl Oral Solution 100 mg/5 milliliters | Do. |
| ANDA 205386 | Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, 60 mg, 100 mg | Do. |
| ANDA 206329 | Fentanyl Citrate Tablets, Equivalent to (EQ) 0.1 mg base, EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, EQ 0.8 mg base | Do. |
| ANDA 206953 | Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg base | Do. |
| ANDA 207270 | Morphine Sulfate Tablets, 15 mg, 30 mg | Do. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 3, 2023. 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 November 3, 2023 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: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21992 Filed 10-3-23; 8:45 am]
BILLING CODE 4164-01-P