Gland Pharma gets FDA tentative approval for Sugammadex Injection

Gland Pharma has secured tentative approval from the US Food and Drug Administration (FDA) for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial.

Sugammadex Injection is a bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Bridion Injection, 100 mg/mL, of Merck Sharp & Dohme (MSD).

It is used for reversing the effects of the muscle relaxants — Vecuronium Bromide and Rocuronium Bromide administered to patients at the time of surgery.

Gland Pharma will roll out Sugammadex Injection through its marketing partner after receiving final approval.

According to IQVIA, the Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial has US sales of around $615 million for 12 months ending in April 2021.

Gland Pharma is a generic injectable focused pharmaceutical company based in Hyderabad, India.