Gland Pharma wins ANDA approval for generic sugammadex sodium injection
The FDA approved Gland's original abbreviated new drug application for sugammadex sodium in two strengths, per an approval letter dated December 20, 2021.
This week's record covers a single FDA approval action for Gland Pharma.
- Sugammadex sodium injection, an intravenous solution, received original ANDA approval from the FDA under application number ANDA214364. The submission was filed as an original application (ORIG 1) and its status is listed as approved (AP), with standard review priority.1 The product is available in two strengths, 200mg base per 2mL and 500mg base per 5mL, both at a concentration of 100mg base per mL.1 The FDA's approval letter for this application is dated December 20, 2021.
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