Notice2025-04106
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight 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 eight 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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]
[Page 12163]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0124]
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of
Eight 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 eight 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of April 14, 2025.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#d79ab6a5a3bfb6f999b0a2aeb2b997b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="561b3724223e37781831232f333816303237783e3e2578313920">[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
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 040063................. ACETIC ACID 2% IN Bausch & Lomb Inc.,
AQUEOUS ALUMINUM 400 Somerset
ACETATE (acetic Corporate Blvd.,
acid, glacial; Bridgewater, NJ
aluminum acetate) 08807.
solution/drop, 2%;
0.79%.
ANDA 060359................. ERYTHROCIN STEARATE Azurity
(erythromycin Pharmaceuticals,
stearate) tablet, Inc., 8 Cabot Rd.,
Equivalent to (EQ) Suite 2000, Woburn,
125 milligrams (mg) MA 01801.
base, EQ 250 mg
base, and EQ 500 mg
base.
ANDA 074307................. Levobunolol Bausch & Lomb Inc.
Hydrochloride (HCl)
solution/drop,
0.25%.
ANDA 074443................. CROLOM (cromolyn Do.
sodium) solution/
drop, 4%.
ANDA 075546................. Carteolol HCl Do.
solution/drop, 1%.
ANDA 075819................. Amantadine HCl CMP Pharma, Inc.,
syrup, 50 mg/5 8026 East Marlboro
milliliters (mL). Rd., P.O. Box 147,
Farmville, NC
27828.
ANDA 091307................. Metoprolol Tartrate American Regent,
injectable, 1 mg/mL. Inc., 5 Ramsey Rd.,
Shirley, NY 11967.
ANDA 207243................. Azelastine HCl Hikma
metered spray, Pharmaceuticals USA
0.2055 mg/spray. Inc., 1809 Wilson
Rd., Columbus, OH
43228.
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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. 2025-04106 Filed 3-13-25; 8:45 am]
BILLING CODE 4164-01-P
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