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Aurobindo Receives FDA Approval for Glycopyrrolate Oral Solution, 1 mg/5 mL

Published: January 02, 2025

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Glycopyrrolate Oral Solution, 1 mg/5 mL. Aurobindo Pharma’s Glycopyrrolate Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Cuvposa® Oral Solution manufactured by Merz Pharmaceuticals, LLC.

Glycopyrrolate Oral Solution are indicated to:

  • Reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).