Mumbai, July 6 -- The aforementioned ANDA is the generic equivalent of LUMRYZ extended-release oral suspension.

LUMRYZ (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. LUMRYZ is a registered trademark of Alkermes plc or its affiliates.

This event marks Granules' second sole first-to-file ANDA, following its earlier success with amphetamine extended-release tablets, the generic equivalent of Dyanavel XR.

Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said: "Securing Sole first-to-file status for our sodium oxybate extended release for oral suspension ANDA is another important miles...