Alembic receives USFDA tentative approval for Fesoterodine Fumarate ER Tablets

Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended Release 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 Furnarate 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.

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