StockWatch
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Pharmaceuticals
USFDA29 Jul 2026, 11:39 am

Gland Pharma Gets USFDA Nod for Sugammadex Injection

AI Summary

Gland Pharma Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sugammadex Injection. The approval covers 200 mg/2 mL and 500 mg/5 mL single-dose vials. This product is bioequivalent to Merck Sharp & Dohme LLC's BRIDION® Injection and is used for reversing neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in surgical patients. Gland Pharma has already launched the product in the US through its marketing partner. The US market for this product was approximately USD 1.6 billion for the twelve months ending April 2026, according to IQVIA.

Key Highlights

  • USFDA approval received for Sugammadex Injection.
  • Product is bioequivalent to Merck's BRIDION® Injection.
  • US sales of the reference drug were USD 1.6 billion.
  • Product launched in the US via marketing partner.
  • Approval covers 200 mg/2 mL and 500 mg/5 mL vials.