Biocon Pharma Receives US FDA Approvals for Lenalidomide and Dasatinib Generics

Biocon
Namkeen ninja, CC BY-SA 4.0, via Wikimedia Commons

Biocon Limited (NSE: BIOCON, BSE: 532523) announced that its wholly-owned subsidiary, Biocon Pharma Limited, has received final approvals from the U.S. Food and Drug Administration (US FDA) for its ANDAs (Abbreviated New Drug Applications) for Lenalidomide capsules and Dasatinib tablets.

The approved Lenalidomide capsules come in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, targeting the treatment of multiple myeloma, lymphoma, and anemia in myelodysplastic syndromes. The Dasatinib tablets, approved in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths, are used to treat Philadelphia chromosome positive chronic myeloid leukemia and acute lymphoblastic leukemia.

Biocon Pharma also received tentative approval for its ANDA for Rivaroxaban Tablets USP, in 2.5 mg, 10 mg, 15 mg and 20 mg strengths. Rivaroxaban is an anticoagulant.

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Also read: Suzlon Powers Low CO2 Steel with Expanded 907 MW Jindal Renewables Order
Published on: March 4, 2025 at 09.25PM GMT.


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