Biocon Pharma Gets USFDA Approval for Blood Pressure Injection

Biocon Ltd. announced on March 24, 2025, that its subsidiary, Biocon Pharma, received approval from the U.S. Food and Drug Administration (USFDA) for its ANDA (Abbreviated New Drug Application) of Norepinephrine Bitartrate Injection USP. The injection is used to raise blood pressure in adult patients experiencing acute hypotension. The approved product is a 4 mg/4 mL (1 mg/mL) single-dose vial.

As of 12:41 PM on March 24, Biocon Ltd Shares were trading at ₹349.50, up 1.57% for the day, despite being down 7.01% over the past 6 months and up 35.62% over the past year.

Product to Be Commercialised in the US

With the approval in place, Biocon Pharma can now commercialise the product in the United States. Norepinephrine is a vasopressor commonly used in critical care and emergency settings. This addition strengthens the company’s portfolio of complex injectable products targeting hospitals and healthcare providers.

Other Recent USFDA Approvals

Earlier this month, on March 4, Biocon received two final approvals from the USFDA. These included Lenalidomide Capsules in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, and Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Lenalidomide is used to treat conditions such as multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes. Dasatinib is prescribed for Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+CML) in both adults and children aged one year and above.

Tentative Approval for Rivaroxaban

Biocon has also received tentative approval for its ANDA for Rivaroxaban Tablets USP. The drug will be available in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. Rivaroxaban is an anticoagulant used to treat and prevent conditions such as deep vein thrombosis, pulmonary embolism, and stroke in patients with nonvalvular atrial fibrillation.

Conclusion 

The approval allows Biocon Pharma to launch the product in the US market. Further regulatory clearances are pending for other drugs in its pipeline.

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