Alembic Pharmaceuticals, Selexipag Tablets Receives Preliminary Approval From USFDA

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Alembic Pharmaceuticals has received USFDA Tentative Approval for Selexipag Tablets in the following strengths: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg.

Alembic Pharmaceuticals Limited (Alembic) announced on Wednesday that its Investigational New Application (ANDA) for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg received provisional approval from the US Food & Drug Administration (USFDA).

The ANDA has been tentatively authorised as therapeutically comparable to Actelion Pharmaceuticals, Ltd.’s Uptravi Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 nicg, and 1,600 mcg (Actelion).

Selexipag Tablets are used to treat pulmonary arterial hypertension (PAH) in order to slow disease development and lower the risk of PAH-related hospitalisation. The market for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg, according to IQVIA, is worth US$ 461 million for the year ending September 2021. Year to date (YTD), Alembic has earned 15 approvals (11 final approvals and 4 preliminary approvals) from the USFDA, for a total of 154 ANDA approvals (134 final approvals and 20 tentative approvals).

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