Granules India Secures USFDA Nod for Generic Glycopyrrolate Oral Solution

Granules India announces that its subsidiary, Granules Pharmaceuticals Inc, has gained approval from the USFDA for its generic version of Glycopyrrolate Oral Solution. The medication is bioequivalent to the reference drug Cuvposa and is indicated for pediatric patients aged three to 16 years with neurological conditions causing drooling.

Granules India has announced that its U.S.-based arm, Granules Pharmaceuticals Inc, received approval from the US Food and Drug Administration (USFDA) for a generic Glycopyrrolate Oral Solution. The medication is indicated for pediatric patients aged three to 16 with neurological conditions associated with drooling.

The approval pertains to the abbreviated new drug application (ANDA) for Glycopyrrolate Oral Solution with a strength of 1mg/5mL. According to the company, this generic drug is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL, manufactured by Merz Pharmaceuticals.

Glycopyrrolate Oral Solution is classified as an anticholinergic medication and specifically targets young patients suffering from drooling because of neurological issues, the statement added.

(With inputs from agencies.)