Granules India gets USFDA nod for generic Glycopyrrolate oral solution

Drugmaker Granules India on Tuesday said its arm Granules Pharmaceuticals Inc. has received approval from the US health regulator for a generic Glycopyrrolate oral solution indicated for pediatric patients having neurological conditions associated with drooling.

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Glycopyrrolate Oral Solution of strength 1mg/5mL, Granules India said in a statement. It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz Pharmaceuticals, LLC, it added.

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients aged three to 16 years who have neurological conditions associated with drooling problems, it added.