Notice2022-06182
Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for FARYDAK (Panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams
Primary source
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Published
March 24, 2022
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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 57 (Thursday, March 24, 2022)</title>
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[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16742-16743]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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DATES: Approval is withdrawn as of March 24, 2022.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, <a href="/cdn-cgi/l/email-protection#a7eccecac5c2d5cbde89ebc2cfd5c1c2cbc3e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="e7ac8e8a8582958b9ec9ab828f9581828b83a7818386c98f8f94c9808891">[email protected]</span></a>.
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
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