USFDA24 Mar 2025, 02:27 pm
Biocon Pharma's ANDA Norepinephrine Bitartrate Injection USP Approved by US FDA
AI Summary
Biocon Pharma Limited, a wholly owned subsidiary of Biocon Ltd, has received approval from the U.S Food and Drug Administration (U.S. FDA) for its ANDA Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) single-dose vial. This approval is for the treatment of acute hypotension in adult patients. The approval adds to Biocon’s growing portfolio of complex drug products, further strengthening its position in the pharmaceutical market.
Key Highlights
- Biocon Pharma received U.S FDA approval for Norepinephrine Bitartrate Injection USP
- Indication: Raising blood pressure in adult patients with acute hypotension
- Product: 4 mg/4 mL (1 mg/mL) single-dose vial
- Added to Biocon’s portfolio of complex drug products
- Strengthens Biocon’s position in the pharmaceutical market