Granules India 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 was s’ second Sole First-to-File ANDA, following its earlier approval for Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR.
“Securing Sole First-to-File status for our Sodium Oxybate Extended Release for Oral Suspension ANDA is another important milestone in our complex generics journey. This achievement reflects the strength of our and regulatory capabilities, while reinforcing our commitment to building a differentiated portfolio,’’ Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India, said in a release on Monday.
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, he added.
Lumryz (sodium oxybate) extended-release oral suspension is indicated in the US for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. Lumryz is a registered trademark of Alkermes plc or its affiliates, the release said.