[Federal Register Volume 89, Number 53 (Monday, March 18, 2024)]
[Notices]
[Page 19327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1180]


Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of 
New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 
Milligrams per Vial

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 the new drug application (NDA) for ALIQOPA 
(copanlisib) for injection, 60 milligrams (mg)/vial, held by Bayer 
HealthCare Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981-
0915. Bayer HealthCare Pharmaceuticals Inc. (Bayer) has voluntarily 
requested that FDA withdraw approval of this application and has waived 
its opportunity for a hearing.

DATES: Approval is withdrawn as of March 18, 2024.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: On September 14, 2017, FDA approved NDA 
209936 for ALIQOPA (copanlisib) for injection, 60 mg/vial, for the 
treatment of adult patients with relapsed follicular lymphoma (FL) who 
have received at least two prior systemic therapies, under the Agency's 
accelerated approval regulations, 21 CFR part 314, subpart H. The 
accelerated approval of ALIQOPA (copanlisib) for injection, 60 mg/vial, 
for FL included required postmarketing trials intended to verify the 
clinical benefit of ALIQOPA.
    FDA met with Bayer on November 8, 2023, to discuss voluntary 
withdrawal of ALIQOPA (copanlisib) for injection, 60 mg/vial, in 
accordance with Sec.  314.150(d) (21 CFR 314.150(d)) because the 
required postmarketing trial did not verify the clinical benefit of 
copanlisib for FL.
    On December 8, 2023, Bayer submitted a letter asking FDA to 
withdraw approval of NDA 209936 for ALIQOPA (copanlisib) for injection, 
60 mg/vial, in accordance with Sec.  314.150(d) and waiving its 
opportunity for a hearing. On December 11, 2023, FDA acknowledged 
Bayer's request for withdrawal of approval of the NDA and waiver of its 
opportunity for a hearing.
    For the reasons discussed above, and in accordance with the 
applicant's request, approval of NDA 209936 for ALIQOPA (copanlisib) 
for injection, 60 mg/vial, and all amendments and supplements thereto, 
is withdrawn under Sec.  314.150(d). Distribution of ALIQOPA 
(copanlisib) for injection, 60 mg/vial, into interstate commerce 
without an approved application is illegal and subject to regulatory 
action (see sections 505(a) and 301(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(a) and 331(d))).

    Dated: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05619 Filed 3-15-24; 8:45 am]
BILLING CODE 4164-01-P