USFDA nod to Zydus Lifesciences cancer drug Dasatinib

Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. (USRLD: Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg).

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. It is also used to treat adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib and adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy.

Dasatinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.

Dasatinib tablets had annual sales of USD 1807.7mn in the United States (IQVIA MAT January 2025). The group now has 415 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences to unveil vaccine against new strain of influenza virus

Medical Dialogues team had earlier reported that its wholly owned subsidiary, Zydus Lifesciences Global FZE had entered into an exclusive licensing, supply and commercialization agreement with Zhuhai Beihai Biotech Co., Ltd for BEIZRAY (Albumin Solubilized Docetaxel Injection), a 505(B)(2) product for the US market.

Read also: Zydus inks pact with Beihai Biotech for cancer drug Beizray commercialization in US