Zydus Gets USFDA Nod for Ibrutinib

  Published 11 months ago

Zydus Lifesciences secures USFDA tentative approval for Ibrutinib tablets, targeting the billion-dollar U.S. market for cancer treatment.

  • Approval covers 140 mg, 280 mg, and 420 mg tablets; production to take place at Ahmedabad SEZ facility.
  • Ibrutinib treats CLL/SLL with 17p deletion and Waldenstrom’s macroglobulinemia; U.S. sales total $2.15 billion annually.
  • Zydus now holds 420 approvals, with 484 ANDAs filed since FY04, strengthening its U.S. generics portfolio.

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