Notice2022-09889
Celgene Corporation and Teva Pharmaceutical Industries Ltd.; Withdrawal of Approval of Peripheral T-Cell Lymphoma Indication for ISTODAX (Romidepsin) for Injection and Romidepsin Injection
Primary source
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Published
May 9, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the peripheral T-cell lymphoma (PTCL) indication for ISTODAX (romidepsin) for injection, approved under new drug application (NDA) 022393, held by Celgene Corporation, 86 Morris Ave., Summit, NJ 07901 (Celgene). We are also announcing the withdrawal of approval of the same indication for Romidepsin injection, approved under NDA 208574, held by Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway, Building A, Parsippany, NJ 07054 (Teva). Celgene and Teva have voluntarily requested that FDA withdraw approval of this indication and have waived their opportunity for a hearing.
Full Text
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<title>Federal Register, Volume 87 Issue 89 (Monday, May 9, 2022)</title>
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[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Page 27644]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0728]
Celgene Corporation and Teva Pharmaceutical Industries Ltd.;
Withdrawal of Approval of Peripheral T-Cell Lymphoma Indication for
ISTODAX (Romidepsin) for Injection and Romidepsin Injection
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it is withdrawing approval of the peripheral T-cell lymphoma
(PTCL) indication for ISTODAX (romidepsin) for injection, approved
under new drug application (NDA) 022393, held by Celgene Corporation,
86 Morris Ave., Summit, NJ 07901 (Celgene). We are also announcing the
withdrawal of approval of the same indication for Romidepsin injection,
approved under NDA 208574, held by Teva Pharmaceuticals USA, Inc., 400
Interpace Parkway, Building A, Parsippany, NJ 07054 (Teva). Celgene and
Teva have voluntarily requested that FDA withdraw approval of this
indication and have waived their opportunity for a hearing.
DATES: Approval was withdrawn as of May 9, 2022.
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#aae1c3c7c8cfd8c6d384e6cfc2d8cccfc6ceeacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="3d7654505f584f5144137158554f5b5851597d5b595c1355554e135a524b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On June 16, 2011, FDA approved an additional
indication for Celgene's new drug application (NDA) 22393 for ISTODAX
(romidepsin) for injection, 10 mg, specifically for treatment of
peripheral T-cell lymphoma (PTCL) in adult patients who have received
at least one prior therapy, under the Agency's accelerated approval
regulations, 21 CFR part 314, subpart H. The accelerated approval of
Celgene's ISTODAX (romidepsin) for injection for PTCL included a
required postmarketing clinical trial intended to verify the clinical
benefit of romidepsin (the Ro-CHOP study) for PTCL.
On March 13, 2020, FDA approved Teva's NDA 208574 for Romidepsin
injection, 10 mg/2 milliliter, for treatment of peripheral T-cell
lymphoma (PTCL) in adult patients who have received at least one prior
therapy, under the Agency's accelerated approval regulations, 21 CFR
part 314, subpart H. The accelerated approval of Teva's Romidepsin
injection for PTCL also included a required postmarketing clinical
trial intended to verify the clinical benefit of romidepsin for PTCL.
Teva's Romidepsin injection product was approved under the 505(b)(2)
approval pathway, and the listed drug relied upon is Celgene's NDA
22393, ISTODAX (romidepsin) for injection.
On August 6, 2020, Celgene submitted high level results from the
Ro-CHOP study to FDA, which indicated the study failed to meet its
primary endpoint of progression free survival. On May 14, 2021, Celgene
informed FDA that after careful consideration, Celgene decided to
voluntarily withdraw the PTCL indication from ISTODAX (romidepsin) for
injection.
On June 17, 2021, Celgene submitted a supplemental NDA proposing to
remove the PTCL indication. On July 14, 2021, Celgene submitted a
letter asking FDA to withdraw approval of the PTCL indication pursuant
to Sec. 314.150(d) (21 CFR 314.150(d)) and waiving its opportunity for
a hearing.
On August 27, 2021, Teva submitted a labeling supplement proposing
to remove the PTCL indication. On September 12, 2021, the Agency
requested Teva voluntarily request withdraw of the PTCL indication
pursuant to Sec. 314.150(d) and waive its opportunity for a hearing.
On September 14, 2021, Teva amended its supplement by submitting a
cover letter requesting withdrawal of approval of the PTCL indication
pursuant to Sec. 314.150(d) and waiving its opportunity for a hearing.
Therefore, under Sec. 314.150(d), approval of the PTCL indications
for ISTODAX (romidepsin) for injection, and Romidepsin injection, is
withdrawn effective May 9, 2022. Withdrawal of approval of the PTCL
indication does not affect any other approved indication(s) for ISTODAX
(romidepsin) for injection or Romidepsin injection.
Dated: May 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09889 Filed 5-6-22; 8:45 am]
BILLING CODE 4164-01-P
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