Alembic pharmaceuticals Ltd on Friday announced that it has received approval from the US Food & Drug Administration (USFDA) for a generic drug used to treat overactive bladder (OAB) in adults.
The company received the final approval from the USFDA for its abbreviated new drug application (ANDA), Fesoterodine Fumarate extended-release tablets in the strength of 4 mg and 8 mg, the firm said in a statement.
The approved medicine is therapeutically equivalent to the reference listed drug (RLD), Toviaz extended-release tablets, 4 mg, and 8 mg, of Pfizer.
The drug is used for the treatment of overactive bladder (OAB) in adults with symptoms of urinary incontinence, urgency, and frequency.
The estimated market size of the Fesoterodine Fumarate Extended-Release tablets, 4 mg, and 8 mg, is approximately US$ 177 million for twelve months ending Sep 2022 according to IQVIA. Alembic had previously received tentative approval for this ANDA.
Shares of the company are trading at Rs. 562.20 (at the time of writing this article) at National Stock Exchange (NSE) down by 1.04%.
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