Document ID: FDA-2023-N-3859-0001
Agency: fda
Document Type: Notice
Title: Dr. Reddy’s Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
Posted Date: 2023-10-04T04:00Z

[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68628-68629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21992]

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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.

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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that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of November 3, 2023.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, [email protected].

SUPPLEMENTARY INFORMATION: 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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

[[Page 68629]]

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 090177.................  Oxycodone and         Dr. Reddy's
                               Acetaminophen         Laboratories, Inc.,
                               Tablets, 3.25         U.S. Agent for Dr.
                               milligrams (mg);      Reddy's
                               2.5 mg, 325 mg; 5     Laboratories SA,
                               mg, 325 mg; 7.5 mg,   107 College Rd.
                               325 mg; 10 mg, 500    East, Princeton NJ
                               mg; 7.5 mg, 650 mg;   08540.
                               10 mg.
ANDA 091313.................  Oxycodone             Do.
                               Hydrochloride (HCl)
                               Tablets, 5 mg, 10
                               mg, 15 mg, 20 mg,
                               30 mg.
ANDA 091670.................  Oxycodone and         Do.
                               Aspirin Tablets,
                               325 mg; 4.8355 mg.
ANDA 203107.................  Oxycodone HCl         Do.
                               Capsules, 5 mg.
ANDA 203335.................  Butalbital, Aspirin,  Do.
                               Caffeine, and
                               Codeine Phosphate
                               Capsules, 325 mg;
                               50 mg; 40 mg; 30 mg.
ANDA 203807.................  Clozapine Tablets,    Do.
                               25 mg, 50 mg, 100
                               mg, 200 mg.
ANDA 204092.................  Oxycodone HCl Oral    Do.
                               Solution 100 mg/5
                               milliliters.
ANDA 205386.................  Morphine Sulfate      Do.
                               Extended-Release
                               Tablets, 15 mg, 30
                               mg, 60 mg, 100 mg.
ANDA 206329.................  Fentanyl Citrate      Do.
                               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.
ANDA 206953.................  Buprenorphine HCl     Do.
                               and Naloxone HCI
                               Tablets, EQ 2 mg
                               base, EQ 0.5 mg
                               base; EQ 8 mg base,
                               EQ 2 mg base.
ANDA 207270.................  Morphine Sulfate      Do.
                               Tablets, 15 mg, 30
                               mg.
------------------------------------------------------------------------

    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