Alembic Pharmaceuticals receives USFDA Final Approval for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg

Alembic Pharmaceuticals Limited (Alembic) today 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 Inc. (Pfizer). Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Refer to our label for full indication.

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022 according to IQVIA. Alembic had previously received tentative approval for this ANDA.

Alembic has a cumulative total of 179 ANDA approvals (157 final approvals and 22 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 567.05 as compared to the previous close of Rs. 570.60. The total number of shares traded during the day was 7041 in over 645 trades.

The stock hit an intraday high of Rs. 573.10 and intraday low of 566.25. The net turnover during the day was Rs. 4009299.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA ANDA FinalApproval FesoterodineFumarate ExtendedRelease Tablets