[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Page 27644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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DATES: Approval was withdrawn as of May 9, 2022.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, [email protected].

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