Alembic Pharma receives tentative approval from USFDA for Fesoterodine Fumarate

2 Feb 2022 , 09:39 AM

In its press release on Wednesday, Alembic Pharmaceuticals Limited announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate ExtendedRelease Tablets, 4 mg, and 8 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg, and 8 mg, of Pfizer Inc. (Pfizer). Fesoterodine Fumarate ExtendedRelease Tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Fesoterodine Fumarate Extended-Release Tablets, 4 mg, and 8 mg have an estimated market·size of US$ 225 million for twelve months ending September 2021 according to IQVIA.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company, engaged in the healthcare sector since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products around the world.

Alembic Pharma is currently trading at Rs769.15 up by Rs7 or 0.92% from its previous closing of Rs762.15 on the BSE. The scrip opened at Rs762.20 and has touched an intraday high and low of Rs772.90 and Rs761.75 respectively.