Granules India Gets Sole First-to-File Status for Sodium Oxybate Extended-Release for Oral Suspension

MT Newswires Live

Jul 06

Granules India (NSE:GRANULES, BOM:532482) has received sole first-to-file (FTF) status for its abbreviated new drug application (ANDA) for Sodium Oxybate Extended-Release for oral suspension, according to a Monday filing to the Indian stock exchanges.

The drug is a generic equivalent of Alkermes' LUMRYZ, an extended-release oral suspension, which is used to treat cataplexy or excessive daytime sleepiness in patients with narcolepsy.

This is Granules' second sole FTF ANDA after Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel.

The company's shares were up over 2% in recent trade.

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