Biocon Pharma, a subsidiary of Biocon Ltd., has received approval from the United States Food and Drug Administration (USFDA) for its norepinephrine bitartrate injection. This medication is crucial for treating acute hypotension, a condition where blood pressure drops to dangerously low levels in adults.
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Expanding Biocon’s Injectable Portfolio
The newly approved norepinephrine bitartrate injection (4 mg/4 mL or 1 mg/mL) in a single-dose vial strengthens Biocon Pharma’s growing portfolio of complex injectable drugs. This green light from the USFDA enables the company to commercialize the product in the U.S., further solidifying its presence in the international pharmaceutical market.
Stock Market Reaction
Following the announcement on March 24, Biocon Ltd.’s shares saw a 1.5% increase, reaching an intraday high of ₹349.2 per share on the Bombay Stock Exchange (BSE). Investors responded positively to the approval, recognizing its potential to enhance Biocon’s revenue streams.
Recent FDA Approvals for Biocon
This isn’t the first regulatory success for Biocon this month. On March 4, the company secured final USFDA approval for two other medications:
- Lenalidomide Capsules (available in strengths of 2.5 mg to 25 mg), a drug used to treat multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes (MDS).
- Dasatinib Tablets (available in strengths of 20 mg to 140 mg), a treatment for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in adults and children aged one year and above.
Additionally, Biocon received tentative approval for Rivaroxaban Tablets USP in 2.5 mg to 20 mg strengths. This anticoagulant helps treat deep vein thrombosis (DVT) and pulmonary embolism while reducing stroke risk in patients with nonvalvular atrial fibrillation.
Future Outlook
With these approvals, Biocon continues to strengthen its foothold in the U.S. pharmaceutical market. The company remains focused on expanding its portfolio, particularly in complex generics and biosimilars.
For more updates on the pharmaceutical industry, visit USFDA’s official website.
