Gland Pharma obtains FDA tentative nod for generic Bridion
Gland Pharma has received tentative approval from the Food and Drug Administration for Sugammadex injection, in dosage strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) in a single-dose vial.
The medication is the generic of Merck Sharp & Dohme’s Bridion injection.
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Sugammadex injection is used to reverse the effects of the muscle relaxants Rocuronium Bromide and Vecuronium Bromide given to patients during surgery.
Gland Pharma will launch the product through its marketing partner on receipt of final approval.
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Sugammadex injection had a market value of approximately $615 million for the 12 months ended April 2021, according to IQVIA.