Gland Pharma receives USFDA approval for Sugammadex Injection

Gland Pharma (Gland or Company), a generic injectable & ophthalmic focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vials.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), BRIDION? Injection of Merck Sharp & Dohme LLC.

The Product is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.