Granules India Wins FDA Nod For Pediatric Drooling Treatment

Granules India announced on Tuesday that its subsidiary, Granules Pharmaceuticals Inc., has received approval from the US Food and Drug Administration for a generic Glycopyrrolate oral solution.

This medication is intended for pediatric patients with neurological conditions that cause drooling. The FDA approved the abbreviated new drug application for the Glycopyrrolate Oral Solution, which has a concentration of 1mg/5mL, Granules India stated.

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.

(With Inputs From PTI)