[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48429-48430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18586]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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DATES: Approval is withdrawn as of August 30, 2021.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, [email protected].

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