Notice2024-05619
Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial
Primary source
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Published
March 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 53 (Monday, March 18, 2024)</title>
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[Federal Register Volume 89, Number 53 (Monday, March 18, 2024)]
[Notices]
[Page 19327]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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DATES: Approval is withdrawn as of March 18, 2024.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, <a href="/cdn-cgi/l/email-protection#62290b0f0007100e1b4c2e070a1004070e06220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="4c0725212e293e2035620029243e2a2920280c2a282d6224243f622b233a">[email protected]</span></a>.
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
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