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).
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company. The Company has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.
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