Biocon’s arm, Biocon Pharma, has received approval for its Norepinephrine Bitartrate Injection in the US, expanding its portfolio of complex injectables. The injection will be used to treat adults with acute hypotension and sodium nitroprusside/control of blood pressure. This approval is in addition to two other drug products that Biocon Pharma has received final US FDA approvals for: Lenalidomide Capsules and Dasatinib Tablets.
Lenalidomide Capsules are indicated for multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia of myelodysplastic syndromes (MDS) in adults. Dasatinib Tablets are approved to treat people aged 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Moreover, Biocon Pharma has received tentative approval for its abbreviated new drug application (ANDA) for Rivaroxaban Tablets USP, which will be supplied in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. Rivaroxaban is an oral anticoagulant used for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as the reduction of stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation.
These regulatory approvals mark a significant milestone for Biocon Pharma, demonstrating its commitment to offering affordable, high-quality complex generics to global markets. The company’s expansion into the US market with these products reinforces its presence in the pharma industry, providing patients with access to essential medicines at an affordable price.