Biocon Pharma gets USFDA approval for BP-raising injection in adults with acute hypotension
Bengaluru: Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, 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.
Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with acute hypotension. Acute hypotension refers to a sudden and significant drop in blood pressure.
"The approval further adds to Biocon’s portfolio of complex drug products," the Company stated in a BSE filing.
Medical Dialogues team had earlier reported the successful results of a pivotal Phase 3, randomized, double-blind, parallel group, multicenter study comparing Yesintek (Biocon Biologics’ biosimilar to Ustekinumab, called YESINTEK) with reference product Stelara (Ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis (PsO).
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