Alembic Pharmaceuticals gets tentative nod from USFDA for generic Selexipag injection

Alembic Pharmaceuticals gets tentative nod from USFDA for generic Selexipag injection

Alembic Pharmaceuticals Ltd on Monday said it has received tentative approval from the US health regulator for its generic version of Selexipag injection used in the treatment of pulmonary arterial hypertension.

The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) Selexipag for injection of strength 1,800 mcg/vial, Alembic Pharmaceuticals said in a statement.

The approved ANDA is therapeutically equivalent to the reference-listed drug product Uptravi for Injection, 1,800 mcg/vial, of Actelion Pharmaceuticals US, Inc, it added.

Alembic Pharma said, based on the most recent update to the USFDA's online paragraph IV database listings, it is the sole first applicant to have filed its ANDA for Selexipag for Injection, 1,800 mcg/vial, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.

As per the USFDA, under the Paragraph IV certification, a company can seek approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

"Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US," it added.

Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalisation.

PAH is a rare, progressive disorder characterised by high blood pressure in the arteries of the lungs.