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Biocon Receives Tentative Approval for Dasatinib Tablets from the US FDA

  • Tue, 06-Feb-2024
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

“Biocon Limited received tentative approval of its ANDA for Dasatinib tablets from the 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 Spokesperson


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Author: BIOCON

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