USFDA gives tentative nod to Biocon for cancer drug Dasatinib
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-07 07:13 GMT | Update On 2024-03-21 16:05 GMT
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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.
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.
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