Granules India Secures Sole First-to-File ANDA for Sodium Oxybate ER

Granules India Limited has announced it secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension. This is the generic equivalent of LUMRYZ® extended-release oral suspension. This marks Granules' second Sole FTF ANDA, following Amphetamine Extended-Release Tablets. The company views this as a significant milestone in its complex generics journey, highlighting its R&D and regulatory capabilities. The drug is indicated for narcolepsy treatment in the US. This achievement reinforces Granules' focus on innovation and expanding its differentiated portfolio in regulated markets.