Alembic Pharma Secures Tentative USFDA Approval for Selexipag

Alembic Pharmaceuticals Limited (Alembic) has announced in a stock exchange filing that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag for Injection, 1,800 mcg/vial.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Uptravi® for Injection, 1,800 mcg/vial, manufactured by Actelion Pharmaceuticals US, Inc. (Actelion). Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I), aimed at delaying disease progression and reducing the risk of hospitalisation for PAH.

According to 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, which includes a Paragraph IV certification under the provisions of the Hatch-Waxman Act.

This implies that upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S. market. This exclusivity period is a significant advantage as it allows Alembic to market its generic version without competition from other generic manufacturers for 180 days.

This tentative approval is a notable achievement for Alembic Pharmaceuticals, adding to its cumulative total of 208 ANDA approvals from the USFDA, which includes 180 final approvals and 28 tentative approvals.

This milestone underscores Alembic’s commitment to expanding its portfolio of approved drugs and enhancing its presence in the US pharmaceutical market. With the potential for generic marketing exclusivity, Alembic is well-positioned to capitalise on this opportunity upon receiving final approval.

Earlier this month, the company received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Bromfenac Ophthalmic Solution, 0.07%.

Bromfenac Ophthalmic Solution 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) prescribed to treat postoperative inflammation and reduce ocular pain in patients who underwent cataract surgery.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been at the forefront of healthcare since 1907.

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