Tuesday, 22 October 2019

Strides receives USFDA approval for Solifenacin Succinate tablets

27 September 2019 | News

Product approval from facility in Alathur, to be marketed by Strides Pharma Inc. in the US market

Strides Pharma Science Limited (Strides) has announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore,  has received approval for Solifenacin Succinate Tablets, 5 mg and 10 mg  from the United  States  Food  &  Drug  Administration  (USFDA).

The  product  is  a  generic  version  of  Vesicare  Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.   According to IQVIA MAT data, the US market for Solifenacin Succinate Tablets, 5 mg and 10  mg  is  approximately  US$  820 Mn.  The  product  will  be manufactured  at  Alathur  facility  in Chennai and will be marketed by Strides Pharma Inc. in the US market.      The company has 102 cumulative ANDA  filings with USFDA of which 66 ANDAs have been  approved and 36 are pending approval. 

Solifenacin Succinate Tablet is an antispasmodic indicated for the  treatment  of  overactive  bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account