Alembic Pharmaceuticals on Wednesday stated it has acquired approval from the US well being regulator to market Selexipag tablets, used to deal with hypertension, within the American market. The firm stated it has acquired tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug utility (ANDA) for Selexipag tablets in strengths of 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg.Alembic’s product is the generic equal to the reference listed drug product (RLD) Uptravi. Selexipag Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH). According to IQVIA, Selexipag tablets have an estimated market measurement of USD 461 million for 12 months ending September 2021. Alembic stated it has to this point acquired 15 product approvals this 12 months.
Alembic gets USFDA nod for generic hypertension treatment drug, Health News, ET HealthWorld
