Notice2023-21992
Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 4, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 88 Issue 191 (Wednesday, October 4, 2023)</title>
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[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68628-68629]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of November 3, 2023.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, <a href="/cdn-cgi/l/email-protection#88c5e9fafce0e9a6c6effdf1ede6c8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="1d507c6f69757c33537a686478735d7b797c3375756e337a726b">[email protected]</span></a>.
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]]
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Application No. Drug Applicant
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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.
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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
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