Biocon Pharma Gains USFDA Approval for Norepinephrine and Key Therapies

24 Mar 2025 , 11:51 PM

Biocon’s arms Biocon Pharma has won approval on its Norepinephrine Bitartrate Injection hit in the US. The Norepinephrine Bitartrate 4 mg/4 mL (1 mg/mL) Injection, Single-Dose Vial is used to treat adults with acute hypotension and sodium nitroprusside/control of blood pressure. This approval augments Biocon Pharma’s complex injectables portfolio and reinforces its footprint in the US pharma market.

Now that the approval is received, the company has gained the right to market the Norepinephrine Bitartrate Injection in the United States, underlining its expansion in the field of injectables. This expands the portfolio of drug products that Biocon Pharma has received final USFDA approvals for (additional 2 drug products).

The first approval is for the 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths of Lenalidomide Capsules. Lenalidomide Capsules are indicated for multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia of myelodysplastic syndromes (MDS) in adults.

This was followed with an approval of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg strengths. Dasatinib is approved to treat people ages 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML).

Also, Biocon Pharma, an arm of the company, has received tentative approval for its abbreviated new drug application (ANDA) for Rivaroxaban Tablets USP from the USFDA.

Rivaroxaban Tablets will be supplied in 2.5 mg, 10 mg, 15 mg and 20 mg strengths. Rivaroxaban is an oral anticoagulant used for multiple conditions, including:

• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Reduction of stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation.

These regulatory approvals mark a significant milestone for Biocon Pharma, reinforcing its commitment to offering affordable, high-quality complex generics to global markets.