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Alembic Pharmaceuticals Gets US FDA's Tentative Approval for Darolutamide Tablets

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Alembic Pharmaceuticals (NSE:APLLTD, BOM:533573) has received tentative approval from the US Food and Drug Administration (US FDA) for its Darolutamide Tablets, 300 mg, according to a Thursday filing to the Indian stock exchanges.

The Darolutamide tablets are therapeutically equivalent to Bayer HealthCare Pharmaceuticals' reference-listed drug Nubeqa Tablets, 300 mg, which are androgen receptor inhibitors used to treat adult patients with prostate cancer.

According to IQVIA estimates, Darolutamide Tablets, 300 mg, have an estimated market size of $3.16 billion for the 12 months ended March.

The company's shares were up over 1% in recent trade.

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