Document ID: FDA-2023-N-5323-0001
Agency: fda
Document Type: Notice
Title: Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications
Posted Date: 2023-12-18T05:00Z

[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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applications be withdrawn.

DATES: Approval is withdrawn as of January 17, 2024.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, [email protected].

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