Alembic Pharmaceuticals Gains Tentative USFDA Nod for Generic Selexipag

Alembic Pharmaceuticals Ltd has secured tentative approval from the US FDA for its generic version of Selexipag, a drug used to treat pulmonary arterial hypertension. This approval, which was filed under Paragraph IV of the Hatch-Waxman Act, may grant the company 180 days of market exclusivity.

Alembic Pharmaceuticals Ltd announced on Monday that it has obtained tentative approval from the US Food & Drug Administration (USFDA) for its generic version of Selexipag injection, a drug used to treat pulmonary arterial hypertension (PAH).

The USFDA approved Alembic's abbreviated new drug application (ANDA) for Selexipag for injection at a strength of 1,800 mcg/vial. This approval states that the product is therapeutically equivalent to the reference drug, Uptravi for Injection, by Actelion Pharmaceuticals US, Inc.

According to Alembic, it is the first applicant to have filed its ANDA for Selexipag containing a Paragraph IV certification under the Hatch-Waxman Act, potentially securing 180 days of generic marketing exclusivity upon final approval. Selexipag is prescribed for PAH to slow disease progression and lower hospitalization risk.

(With inputs from agencies.)