USFDA approves Fesoterodine Fumarate Extended-Release tablets

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

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Mumbai: Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer.

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

According to IQVIA, the market for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, is worth US$ 177 million in the fiscal year ending September 2022.

Alembic had previously received tentative approval for this ANDA.

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