Notice2023-27661
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications
Primary source
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Published
December 18, 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 two new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 88 Issue 241 (Monday, December 18, 2023)</title>
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[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87433]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27661]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5323]
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two
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 two new drug applications (NDAs) 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applications be withdrawn.
DATES: Approval is withdrawn as of January 17, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#bdf6d4d0dfd8cfd1c493f1d8d5cfdbd8d1d9fddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="9dd6f4f0fff8eff1e4b3d1f8f5effbf8f1f9ddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The applicants listed in the table 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 under Sec. 314.150(c) is
without prejudice to refiling.
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Application No. Drug Applicant
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NDA 021455............. Boniva (ibandronate Hoffmann-La Roche,
sodium) Tablets, Inc. c/o Genentech,
equivalent to (EQ) 2.5 Inc., 1 DNA Way,
milligrams (mg) base South San Francisco,
and EQ 150 mg base. CA 94080-4990.
NDA 022424............. Flowtuss (guaifenesin Chartwell RX Sciences,
200 mg/5 milliliters LLC, 77 Brenner Dr.,
(mL) and hydrocodone Congers, NY 10920.
bitartrate 2.5 mg/5
mL) Oral Solution.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 17, 2024. 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 listed in the table without an approved NDA
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 the table that are in inventory on January 17, 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: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27661 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P
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