Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial, 19327 [2024-05619]
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Federal Register / Vol. 89, No. 53 / Monday, March 18, 2024 / Notices
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Lauren K. Roth,
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[FR Doc. 2024–05686 Filed 3–15–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
PO 00000
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19327
Approval is withdrawn as of
March 18, 2024.
DATES:
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, Kimberly.Lehrfeld@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
FDA met with Bayer on November 8,
2023, to discuss voluntary withdrawal
of ALIQOPA (copanlisib) for injection,
60 mg/vial, in accordance with
§ 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
§ 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 § 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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]]>Agencies
[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.
-----------------------------------------------------------------------
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
