USFDA gives tentative nod to Gland Pharma for generic muscle relaxant drug

Gland Pharma will launch the product through its marketing partner on receipt of final approval.

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USFDA
Picture: Pixabay

Last Updated on October 11, 2021 by The Health Master

Gland Pharma Limited, a generic injectable focused pharmaceutical company, received tentative approval from the United States Food and Drug Administration (USFDA) for sugammadex injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial

This injection is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Bridion injection, 100 mg/mL, of Merck Sharp & Dohme Corp. (Merck Sharp & Dohme).

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.

The sugammadex injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial has US sales of approximately US$615 million for twelve months ending in April 2021, according to IQVIA.

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