Granules India secures FTF status for Sodium Oxybate ER for Oral Suspension ANDA

Granules India announced that it has secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ? extended-release oral suspension.

This achievement marks Granules' second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR?, and further demonstrates the company's growing capabilities in developing and advancing complex, differentiated generic products for the U.S market.

The Sole First-to-File designation further strengthens Granules position in the complex generics segment and underscores the Company's continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets.

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.