Shares of Biocon Ltd were trading in the green and 2% higher on 24 March after the company’s subsidiary announced securing approval from the USFDA for norepinephrine bitartrate injection.
Biocon Pharma has expanded its portfolio of complex injectable products with the approval of norepinephrine bitartrate injection (4 mg/4 mL, 1 mg/mL) in a single-dose vial, the company announced in a stock exchange filing.
Norepinephrine bitartrate injection is a critical drug used to elevate blood pressure in adults experiencing acute hypotension. With this approval, Biocon Pharma is now authorized to commercialize the product in the US market, strengthening its presence in the complex drug segment.
Earlier, on 4 March, the company secured final USFDA approval for two key drug products:
- Lenalidomide Capsules (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg) – Used in the treatment of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and myelodysplastic syndromes (MDS)-related anaemia in adults.
- Dasatinib Tablets (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg) – Approved for treating Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in adults and children aged one year and above.
Additionally, Biocon Pharma received tentative USFDA approval for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP, available in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths.
Rivaroxaban is prescribed for treating deep vein thrombosis (DVT) and pulmonary embolism (PE) and reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, among other conditions.
At 2:58 pm, the shares of Biocon were trading 0.89% higher at Rs 350.60 on NSE.
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