Alembic Pharma Secures Tentative USFDA Nod for Bosutinib 400 mg Tablets

Alembic Pharmaceuticals Ltd has obtained tentative approval from the USFDA for its Bosutinib tablets, used to treat specific types of cancer. The approval pertains to the 400 mg strength tablets and is the equivalent of PF Prism CV's Bosulif tablets. Alembic previously secured final approval for 100 mg and 500 mg strengths.

Alembic Pharmaceuticals Ltd has received tentative approval from the US Food & Drug Administration for its Bosutinib tablets, a significant development in cancer treatment. Announced on Monday, the approval is for the 400 mg strength, important for treating specific chronic myelogenous leukemia (CML) cases.

The approval by USFDA represents a supplemental abbreviated new drug application (sANDA) for Bosutinib tablets 400 mg. These tablets are therapeutically equivalent to the reference drug Bosulif tablets by PF Prism CV. This equivalence ensures the medication meets the stringent guidelines for effectiveness and safety.

This decision follows Alembic's previous success in gaining final approval for its 100 mg and 500 mg Bosutinib tablets. Bosutinib plays a critical role in treating adult patients with chronic, accelerated, or blast phase Ph+ CML, especially those newly diagnosed or resistant to prior therapies.

(With inputs from agencies.)