September 18, 2025

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USFDA Gives Tentative Nod To Biocon For Cancer Drug Dasatinib

Biocon Limited Receives Tentative Approval

Biocon Limited Receives Tentative Approval for Dasatinib Tablets

Bangalore: Biocon Limited has received tentative approval of its Abbreviated New Drug Application (ANDA) for Dasatinib tablets from the United States Food and Drug Administration (US FDA), for strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

This product is indicated for use in the treatment of Philadelphia chromosome positive chronic myeloid leukemia in adults. It is also used to treat Philadelphia chromosome positive acute lymphoblastic leukemia in adults with resistance or intolerance to prior therapy.

"The approval will further strengthen Biocon’s portfolio of vertically integrated, complex drug products.” Company's Spokesperson informed in a statement to stock exchange.

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  • Biocon Chief says budget outlines comprehensive roadmap for sustained economic growth

Biocon Limited, publicly listed in 2004, is an innovation-led global biopharmaceuticals company. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

Read also:

  • Powered by innovative drugs, pharma industry can be worth USD 200 billion by 2030: Biocon Chief

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