Document ID: FDA-2022-N-0352-0001
Agency: fda
Document Type: Notice
Title: Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams
Posted Date: 2022-03-24T04:00Z

[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16742-16743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06182]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0352]

Secura Bio, Inc.; Withdrawal of Approval of New Drug Application 
for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 
20 Milligrams

AGENCY: Food and Drug Administration, Health and Human Services (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 FARYDAK 
(panobinostat) Capsules, 10 milligrams (mg), 15 mg, and 20 mg, held by 
Secura Bio, Inc., 1995 Village Center Circle, Suite 128, Las Vegas, NV 
89134. Secura Bio, Inc. 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DATES: Approval is withdrawn as of March 24, 2022.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 February 23, 2015, FDA approved NDA 
205353 for FARYDAK (panobinostat) Capsules, 10 mg, 15 mg, and 20 mg, in 
combination with bortezomib and dexamethasone for the treatment of 
patients with multiple myeloma who have received at least two prior 
regimens, including bortezomib and an immunomodulatory agent, under the 
Agency's accelerated approval regulations, 21 CFR part 314, subpart H. 
The accelerated approval of FARYDAK (panobinostat) Capsules, 10 mg, 15 
mg, and 20 mg, for multiple myeloma included a required postmarketing 
trial intended to verify the clinical benefit of FARYDAK.
    On September 24, 2021, FDA published the Federal Register notice 
``Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment 
of a Public Docket; Request for Comments,'' announcing that FARYDAK 
(panobinostat) Capsules would be discussed at an Oncologic Drug 
Advisory Committee Meeting (ODAC) scheduled for December 2, 2021 (86 FR 
53067). On November 19, 2021, FDA met with Secura Bio, Inc. to discuss 
the planned ODAC meeting. The topics discussed included the lack of 
initiation of the postmarketing trial intended to verify clinical 
benefit.

[[Page 16743]]

    On November 22, 2021, Secura Bio, Inc. submitted a letter asking 
FDA to withdraw approval of NDA 205353 for FARYDAK (panobinostat) 
Capsules, 10 mg, 15 mg, and 20 mg, pursuant to Sec.  314.150(d) (21 CFR 
314.150(d)) and waiving its opportunity for a hearing. In the letter, 
Secura Bio, Inc. stated they are requesting withdrawal of approval of 
the NDA for FARYDAK because it was not feasible for them to complete 
the required postmarketing clinical trials. On November 26, 2021, FDA 
acknowledged Secura Bio, Inc.'s request for withdrawal of approval of 
the NDA and waiver of its opportunity for hearing. FDA also cancelled 
the ODAC meeting scheduled for December 2, 2021, since the applicant's 
withdrawal request made discussion at an advisory committee meeting 
moot.
    For the reasons discussed above, and in accordance with the 
applicant's request, approval of NDA 205353 for FARYDAK (panobinostat) 
Capsules, 10 mg, 15 mg, and 20 mg, and all amendments and supplements 
thereto, is withdrawn under Sec.  314.150(d). Distribution of FARYDAK 
(panobinostat) Capsules, 10 mg, 15 mg, and 20 mg, 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 18, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-06182 Filed 3-23-22; 8:45 am]
BILLING CODE 4164-01-P