Alembic Pharmaceuticals receives US FDA tentative approval for Selexipag tablets

Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (FDA) 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 (RLD) product Uptravi tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg, of Actelion Pharmaceuticals, according to a statement from the company.

The statement further said that Selexipag tablets are indicated for the treatment of Pulmonary Arterial Hypertension (PAH) to delay disease progression and reduce the risk of hospitalisation 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 $461 million for twelve months ending September 2021, according to IQVIA.

Alembic has received year to date (YTD) 15 approvals (11 final approvals and four tentative approvals) and a cumulative total of 154 ANDA approvals (134 final approvals and 20 tentative approvals) from US FDA, it concluded.