MUMBAI, Mar 5: Pharma major, Biocon Pharma, has received final approvals from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug applications (ANDAs) for Lenalidomide Capsules and Dasatinib Tablets.
It is used to treat types of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anaemia in myelodysplastic syndromes (MDS) in adults.
Dasatinib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adults and children of 1 year of age and older. It is also used to treat Ph+CML and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) in adults after other medicines (eg, imatinib) or treatments did not work well. Dasatinib is also used in combination with chemotherapy to treat newly diagnosed Ph+ALL in children 1 year of age and older.
Additionally, Biocon Pharma has received tentative approval for its ANDA for Rivaroxaban Tablets USP, which is used to prevent blood clots and reduce the risk of stroke.
“These approvals further add to Biocon’s portfolio of vertically integrated, complex drug products,” the company release said. (UNI)
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