Notice2024-16627
Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Primary source
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Published
July 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 89 Issue 145 (Monday, July 29, 2024)</title>
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[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Page 60902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16627]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3248]
Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23
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 23 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of August 28, 2024.
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#aee3cfdcdac6cf80e0c9dbd7cbc0eec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="bef3dfcccad6df90f0d9cbc7dbd0fed8dadf90d6d6cd90d9d1c8">[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 073462................. Tolmetin Sodium Fosun Pharma USA
capsule, Equivalent Inc., 104 Carnegie
to (EQ) 400 Center, Suite 204,
milligrams (mg) Princeton, NJ
base. 08540.
ANDA 073588................. Tolmetin Sodium Do.
tablet, EQ 200 mg
base.
ANDA 074002................. Tolmetin Sodium Do.
tablet, EQ 600 mg
base.
ANDA 075631................. Ketorolac Baxter Healthcare
Tromethamine Corp., One Baxter
injectable, 15 mg/ Parkway, Deerfield,
milliliters (mL) IL 60015.
and 30 mg/mL.
ANDA 076427................. Milrinone Lactate Do.
injectable, EQ 1 mg
base/mL.
ANDA 076791................. Haloperidol Lactate Do.
injectable, EQ 5 mg
base/mL.
ANDA 076828................. Haloperidol Lactate Do.
injectable, EQ 5 mg
base/mL.
ANDA 077040................. Citalopram Fosun Pharma USA
Hydrobromide Inc.
tablet, EQ 10 mg
base, EQ 20 mg
base, EQ 40 mg base.
ANDA 077947................. Fluconazole Baxter Healthcare
injectable, 200 mg/ Corp.
100 mL (2 mg/mL)
and 400 mg/200 mL
(2 mg/mL).
ANDA 078197................. Granisetron Do.
Hydrochloride (HCl)
injectable, EQ 0.1
mg base/mL (EQ 0.1
mg base/mL).
ANDA 079045................. Bicalutamide tablet, Fresenius Kabi USA,
50 mg. LLC, Three
Corporate Dr., Lake
Zurich, IL 60047.
ANDA 085787................. Trifluoperazine HCl Fosun Pharma USA
concentrate, EQ 10 Inc.
mg base/mL.
ANDA 086808................. Cyproheptadine HCl Do.
tablet, 4 mg.
ANDA 087774................. Phenylbutazone Do.
capsule, 100 mg.
ANDA 088602................. Pseudoephedrine HCl; Do.
Triprolidine HCl
tablet, 60 mg;
2.5.mg.
ANDA 090367................. Levofloxacin tablet, Celltrion USA, Inc.,
250 mg, 500 mg, 750 U.S. Agent for
mg. Celltrion, Inc.,
One Evertrust
Plaza, Suite 1207,
Jersey City, NJ
07302.
ANDA 091049................. Ceftriaxone Sodium EAS Consulting
injectable, EQ 250 Group, LLC, U.S.
mg base/vial, EQ Agent for Astral
500 mg base/vial, SteriTech Pvt.
EQ 1 gram (g) base/ Ltd., 1700 Diagonal
vial, EQ 2 g base/ Rd., Suite 750,
vial. Alexandria, VA
22314.
ANDA 091436................. Levofloxacin Baxter Healthcare
injectable, EQ 500 Corp.
mg/20 mL (EQ 25 mg/
mL).
ANDA 207032................. Melphalan HCl USWM, LLC, 4441
injectable, EQ 50 Springdale Rd.,
mg base/vial. Louisville, KY
40241.
ANDA 207101................. Sumatriptan Baxter Healthcare
Succinate Corp.
injectable, EQ 6 mg
base/0.5 mL (EQ 12
mg base/mL).
ANDA 211959................. Clobazam tablet, 10 Celltrion USA, Inc.,
mg and 20 mg. U.S. Agent for
Celltrion, Inc.
ANDA 212053................. Chlorzoxazone AptaPharma Inc.,
tablet, 375 mg and 1533 Union Ave.,
750 mg. Pennsauken, NJ
08110.
ANDA 215065................. Methocarbamol Baxter Healthcare
solution, 1 g/10 mL Corp.
(100 mg/mL).
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of August
28, 2024. 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 August 28, 2024 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: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16627 Filed 7-26-24; 8:45 am]
BILLING CODE 4164-01-P
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