[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8242-8243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-03411]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1224]
Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.;
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 Agency) is
withdrawing approval of 11 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 23, 2026.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 8243]]
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, [email protected].
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Table 1--ANDAs for Which Approval Is Withdrawn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 065366................. Azithromycin, Masuu Global
tablet, Equivalent Solutions LLC, U.S.
to (EQ) 500 Agent for Extrovis
milligram (mg) base. AG, 2255 Glades
Rd., Suite 324A,
Boca Raton, FL
33431.
ANDA 078022................. Propranolol Do.
hydrochloride
(HCl), extended-
release capsule, 60
mg, 80 mg, 120 mg,
and 160 mg.
ANDA 090665................. Lidocaine HCl, Do.
injectable, 2%.
ANDA 201530................. Methotrexate sodium Do.
preservative free,
injectable, EQ 1
gram (gm) base/40
milliliters (mL)
(EQ 25 mg base/mL).
ANDA 201689................. Ifosfamide, Do.
injectable, 1 gm/20
mL (50 mg/mL) and 3
gm/60 mL (50 mg/mL).
ANDA 203063................. Clindamycin Do.
palmitate HCl, for
oral solution, EQ
75 mg base/5 mL.
ANDA 203122................. Fluorouracil, cream, Do.
0.5%.
ANDA 203586................. Lamivudine, tablet, Breckenridge
150 mg. Pharmaceutical,
Inc., 200 Connell
Dr., Suite 4200,
Berkeley Heights,
NJ 07922.
ANDA 204430................. Riluzole, tablet, 50 Cardinal Health
mg. Regulatory
Sciences, U.S.
Agent for Daito
Pharmaceutical Co.,
Ltd., 7400 W 110th
St., Suite 150,
Overland Park, KS
66210.
ANDA 208643................. Paliperidone, Lupin
extended-release Pharmaceuticals,
tablet, 1.5 mg, 3 Inc., U.S. Agent
mg, 6 mg, and 9 mg. for Lupin Limited,
400 Campus Dr.,
Somerset, NJ 08873.
ANDA 208817................. Oxycodone HCl, Hikma
solution, 5 mg/5 mL. Pharmaceuticals USA
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, are hereby withdrawn as of March
23, 2026. 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 March 23, 2026 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03411 Filed 2-19-26; 8:45 am]
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