Alembic Pharmaceuticals receives USFDA Tentative Approval for Selexipag Tablets

Alembic Pharmaceuticals Limited (Alembic) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Uptravi Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 nicg, and 1,600 mcg, of Actelion Pharmaceuticals, Ltd. (Actelion). Selexipag Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalization for PAH.

Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg have an estimated market size of US$ 461 million for twelve months ending September 2021 according to IQVIA.

Alembic has received year to date (YTD) 15 approvals (11 final approvals and 4 tentative approvals) and a cumulative total of 154 ANDA approvals (134 final approvals arid 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 818.55 as compared to the previous close of Rs. 791.45. The total number of shares traded during the day was 56336 in over 2103 trades.

The stock hit an intraday high of Rs. 821.00 and intraday low of 791.00. The net turnover during the day was Rs. 45595477.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticalsLimited INE901L01018 TentativeApproval SelexipagTablets ANDA