Alembic Pharma Selexipag bags USFDA okay
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Drugmaker, Alembic Pharmaceuticals Limited, announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Uptravi Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg, of Actelion Pharmaceuticals, Ltd. (Actelion).
For more details, check out the full story on the link below:
Alembic Pharma Gets USFDA Nod For Pulmonary Arterial Hypertension Drug Selexipag
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