Notice2025-04107
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Four Abbreviated New Drug Applications
Primary source
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Published
March 14, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 90 Issue 49 (Friday, March 14, 2025)</title>
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[Federal Register Volume 90, Number 49 (Friday, March 14, 2025)]
[Notices]
[Pages 12163-12164]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04107]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0104]
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of
Four Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of four 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of April 14, 2025.
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, 301-
796-3471, <a href="/cdn-cgi/l/email-protection#95d8f4e7e1fdf4bbdbf2e0ecf0fbd5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="723f1300061a135c3c15070b171c321416135c1a1a015c151d04">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 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
[[Page 12164]]
under Sec. 314.150(c) is without prejudice to refiling.
Table 1--ANDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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ANDA 040065............... Prednisolone Sodium Bausch & Lomb Inc.,
Phosphate solution/ 400 Somerset
drops, Equivalent to Corporate Blvd.,
(EQ) 0.11% phosphate. Bridgewater, NJ
08807.
ANDA 202031............... Gemcitabine American Regent,
Hydrochloride (HCl) Inc., 5 Ramsey Rd.,
injectable, EQ 200 Shirley, NY 11967.
milligrams (mg) base/
vial and EQ 1 gram
(g) base/vial.
ANDA 202562............... Dactinomycin Do.
injectable, 0.5 mg/
vial.
ANDA 213390............... Vigabatrin for KubsTech Inc., U.S.
solution, 500 mg/ Agent for Propel
packet. Pharma Corp, 22
Tanner Dr.,
Princeton, NJ 08540.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of April 14,
2025. Approval of each entire application is withdrawn, including any
strengths and dosage forms inadvertently missing from table 1.
Introduction or delivery for introduction into interstate commerce of
products listed in table 1 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 table 1 that are in inventory on April 14, 2025 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: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04107 Filed 3-13-25; 8:45 am]
BILLING CODE 4164-01-P
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