 "Alembic Pharmaceuticals ups its US game plan, acquires Orit")
Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market Selexipag tablets, used to treat high blood pressure, in the American market.
The company said it has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (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 equivalent 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 size of USD 461 million for 12 months ending September 2021.
Alembic said it has so far received 15 product approvals this year.
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