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.

制药商印度颗粒公司（Granucles India）周二表示，其arm Granucles Pharmaceuticals Inc已获得美国卫生监管机构的批准，可用于治疗患有流口水相关神经系统疾病的儿科患者。印度颗粒剂公司在一份声明中表示，美国食品和药物管理局（USFDA）的批准是针对浓度为1mg/5mL的格隆溴铵口服溶液的缩写新药申请（ANDA）。

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.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

它补充道，它与参考药物Cuvposa口服溶液（1 mg/5 mL Merz Pharmaceuticals，LLC）具有生物等效性和治疗等效性。。（您现在可以订阅我们的经济时报WhatsApp频道）（您现在可以订阅我们的经济时报WhatsApp频道）。