Alembic Pharma gets tentative USFDA nod for fesoterodine fumarate extended-release tablets

Alembic Pharma gets tentative USFDA nod for fesoterodine fumarate extended-release tablets

By, Admin 2 March 2022

These tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Alembic Pharmaceuticals on Wednesday said it has received tentative approval from the US health regulator for its generic version of fesoterodine fumarate extended-release tablets, used for overactive bladder in adults with symptoms of urinary incontinence, urgency, and frequency. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for fesoterodine fumarate extended-release tablets is for strengths of 4 mg and 8 mg, the company said in a statement. 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," it added. These tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

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