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The Hindu·2 min read·medium

Granules secures FTF status for CNS depressant generic

T
The Hindu Bureau
Granules secures FTF status for CNS depressant generic
AI Summary

Granules India has secured sole first-to-file status for a generic version of the narcolepsy drug Lumryz. This achievement marks a significant step in the company's strategy to expand its portfolio of complex generic pharmaceuticals in the U.S. market.

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 ER oral suspension of Alkermes plc.

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