Baxter Expands Pharmaceuticals Portfolio with New Injectable Products in the U.S.
Enforcement Report - Week of February 28, 2024
FDA Confirms Paragraph IV Patent Litigation for Norepinephrine Bitartrate in 0.9 % Sodium Chloride
Enforcement Report - Week of April 19, 2023
Enforcement Report - Week of March 8, 2023
Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market generic blood pressure lowering medication in the American market. The company has received final approval from the US Food and Drug Administration (USFDA) to sell Norepinephrine Bitartrate Injection, Zydus Lifesciences said in a statement.
Zydus Pharma Generic Norepinephrine Bitartrate Receives Approval in the U.S.
Enforcement Report - Week of March 30, 2022
Enforcement Report - Week of March 02, 2022
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of premix Norepinephrine Bitartrate in 5% Dextrose Injection (norepinephrine). Norepinephrine is indicated to raise blood pressure in adult patients with severe, acute hypotension (low blood pressure). Baxter’s formulation of norepinephrine is the first and only manufacturer-prepared ready-to-use formulation and is available in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) strengths. Please see Important Risk Information and link to full Prescribing Information below.