Alembic Pharma gets USFDA final approval for Fesoterodine Fumarate

The drug maker has received final approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Fesoterodine Fumarate extended-release tablets, 4 mg and 8 mg.

Alembic had previously received tentative approval for Fesoterodine Fumarate. It is therapeutically equivalent to the reference listed drug (RLD), Toviaz extended-release tablets, 4 mg and 8 mg, of Pfizer.

The drug is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency and frequency.

Fesoterodine Fumarate had an estimated market size of $177 million for twelve months ending September 2022 according to IQVIA.

Alembic has received a cumulative total of 179 ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.

Shares of Alembic Pharmaceuticals were down 0.24% to Rs 565.70 on the BSE.

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