Alembic Pharma shares gains on USFDA tentative approval for Selexipag for injection

Alembic Pharmaceuticals

Alembic Pharmaceuticals share price rose in the early morning trade on July 15 after the company received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Selexipag for injection, 1,800 mcg/vial.

At 09:37am, Alembic Pharmaceuticals was quoting at Rs 975.95, up 0.34 percent, on the BSE.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Uptravi for injection, 1,800 mcg/vial, of Actelion Pharmaceuticals US, Inc. (Actelion).

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

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Based on the most recent update to the FDA’s online paragraph IV database listings, Alembic 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 HatchWaxman Act. Upon final approval of this ANDA by USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US.

The company has a cumulative total of 208 ANDA approvals (180 final approvals and 28 tentative approvals) from USFDA.

The share touched a 52-week high of Rs 1,093.05 and a 52-week low of Rs 641.65 on 21 February, 2024 and 14 July, 2023, respectively.

Currently, the stock is trading 10.8 percent below its 52-week high and 51.96 percent above its 52-week low.

The share price jumped 50 percent in the last one-year.