Alembic Pharma receives tentative USFDA approval for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg

Alembic Pharmaceuticals Limited (Alembic) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate ExtendedRelease 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.

Alembic has received year to date (YTD) 20 approvals (14 final approvals and 6 tentative approvals) and a cumulative total of 159 ANDA approvals (137 final approvals arid 22 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 762.15 as compared to the previous close of Rs. 756.65. The total number of shares traded during the day was 6461 in over 443 trades.

The stock hit an intraday high of Rs. 766.45 and intraday low of 752.95. The net turnover during the day was Rs. 4922310.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA TentativeApproval ANDA FesoterodineFumarate