Shares of pharmaceutical major Biocon Ltd were trading in the green and 3% higher on 5 March after the company that its wholly-owned subsidiary secured final approval for Lenalidomide capsules and Dasatinib tablets from USFDA. 

In its regulatory filing, the company said, “This is to inform you that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received final approvals for its ANDAs from the US Food and Drug Administration (USFDA).”

Lenalidomide Capsules are available in doses of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. This medication is used to treat multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anaemia linked to myelodysplastic syndromes (MDS) in adults.

Meanwhile, Dasatinib Tablets come in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. It is prescribed for Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in adults and children aged one year and older. Additionally, it is used to treat Ph+ CML and Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) in adults when previous treatments, such as imatinib, are ineffective. In children aged one year and older, Dasatinib can also be used alongside chemotherapy for newly diagnosed Ph+ ALL.

Biocon Pharma has also received tentative approval for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, available in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg, according to the company’s statement.

Rivaroxaban is indicated for treating deep vein thrombosis and pulmonary embolism, as well as reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, among other conditions.

These approvals further strengthen Biocon’s portfolio of complex, vertically integrated drug products, the company added.

At 3:21 pm, the shares of Biocon were trading 3.19% higher at Rs 324.85 on NSE.

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