Biocon Pharma Receives U.S. FDA Approval for Norepinephrine Bitartrate Injection

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) single-dose vial.

About the Product:

  • Indication: Used to raise blood pressure in adult patients with acute hypotension (low blood pressure).
  • Category: A critical care medication commonly used in hospital settings.

Significance of the Approval:

This approval strengthens Biocon Pharma’s portfolio of complex drug products and reinforces its commitment to providing high-quality, affordable generics to the U.S. market.

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