Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder in adults with symptoms of urge urinary incontinence, urgency, and frequency.
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