Notice2021-18586
Breckenridge Pharmaceutical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 Milligrams and 10 Milligrams
Primary source
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Published
August 30, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Berlin, CT 06037 (Breckenridge). Breckenridge requested withdrawal of this application and has waived its opportunity for a hearing.
Full Text
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<title>Federal Register, Volume 86 Issue 165 (Monday, August 30, 2021)</title>
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[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48429-48430]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18586]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0790]
Breckenridge Pharmaceutical, Inc.; Withdrawal of Approval of
Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5
Milligrams and 10 Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of the abbreviated new drug application (ANDA) for solifenacin
succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge
Pharmaceutical, Inc., 15 Massirio Dr., Berlin, CT 06037 (Breckenridge).
Breckenridge requested withdrawal of this application and has waived
its opportunity for a hearing.
DATES: Approval is withdrawn as of August 30, 2021.
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#6e2507030c0b1c021740220b061c080b020a2e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="084361656a6d7a647126446d607a6e6d646c486e6c692660607b266f677e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On May 20, 2019, FDA approved ANDA 209818
for solifenacin succinate tablets, 5 mg and 10 mg, for the treatment of
overactive bladder with symptoms of urge urinary incontinence, urgency,
and urinary frequency. On January 23, 2020, Breckenridge issued a field
alert report that solifenacin succinate tablets, 5 mg and 10 mg, may
convert to solifenacin tartrate tablets during manufacturing due to an
interaction between solifenacin succinate and tartartic acid, which is
an inactive ingredient in this drug product's formulation. On January
24, 2020, Breckenridge executed a Class II Recall (Retail-Level) of all
solifenacin succinate tablet product lots that were distributed to
market. Breckenridge cannot market its solifenacin succinate tablet
product under the current approval conditions for ANDA 209818. To the
extent that its active ingredient has converted from solifenacin
succinate to solifenacin tartrate, the product Breckenridge has
distributed under ANDA 209818 is misbranded.
After discussions with FDA, on April 21, 2020, Breckenridge
requested that FDA withdraw approval of ANDA 209818 for solifenacin
succinate tablets under Sec. 314.150(d) (21 CFR 314.150(d)) and waived
its opportunity for a hearing. For the reasons discussed above, and in
accordance with the applicant's request, approval of ANDA 209818
solifenacin succinate tablets, and all amendments and supplements
thereto, is withdrawn under Sec. 314.150(d). Distribution of
solifenacin succinate tablets into interstate commerce without an
approved application is illegal and subject to regulatory action (see
sections 505(a)
[[Page 48430]]
and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18586 Filed 8-27-21; 8:45 am]
BILLING CODE 4164-01-P
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