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).