Biocon Pharma Secures USFDA Nod for Norepinephrine and Vital Therapies

The US has approved Biocon Pharma, a subsidiary of Biocon, for its Norepinephrine Bitartrate Injection. Adults with acute hypotension can be treated with the 4 mg/4 mL (1 mg/mL) Norepinephrine Bitartrate Injection in a Single-Dose Vial, which also controls blood pressure with sodium nitroprusside. With this endorsement, Biocon Pharma's presence in the US pharmaceutical industry is strengthened and its portfolio of complicated injectables is expanded.With the approval obtained, the company is now authorized to promote the Norepinephrine Bitartrate Injection in the United States, emphasizing its growth in the injectable market. This increases the range of drug products for which Biocon Pharma has obtained final USFDA approvals (an extra 2 drug products).

Lenalidomide capsules in the following strengths have received the initial approval: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Lenalidomide capsules are prescribed for adult patients with multiple myeloma, anemia of myelodysplastic syndromes (MDS), follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.

Following this, dasatinib tablets in strengths of 20, 50, 70, 80, 100, and 140 mg were approved. Patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) who are one year of age or older may receive dasatinib. Also, the USFDA has tentatively approved Biocon Pharma's (the company's subsidiary) abbreviated new drug application (ANDA) for Rivaroxaban Tablets USP.