Granules Secures Sole First-to-File Status for Generic Narcolepsy Drug LUMRYZ in US
New Delhi: Granules India Limited has secured Sole First-to-File (FTF) status from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic version of LUMRYZ extended-release oral suspension.
The company said this marks its second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR, highlighting its growing capabilities in developing complex and differentiated generic products for the US market.
Commenting on the development, Dr Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited, said, "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 R&D and regulatory capabilities, while reinforcing our commitment to building a differentiated portfolio. We remain focused on expanding patient access to affordable treatment options and delivering sustainable long-term growth."
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The company stated that the Sole First-to-File designation further strengthens its position in the complex generics segment and underscores its continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets.
LUMRYZ (sodium oxybate) extended-release oral suspension is approved 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.
