Priority review sets up Sage for shot at December approval
CNS specialist Sage Therapeutics (Nasdaq: SAGE) could have its first commercial product by Christmas.
On Wednesday, the US Food and Drug Administration (FDA) accepted the filing of a New Drug Application (NDA) for the US biotech’s lead product candidate, an intravenous (IV) formulation of brexanolone (SAGE-547), for postpartum depression (PPD).
The FDA has also granted the NDA priority review status and assigned a Prescription Drug User Fee Act target date of December 19 this year.
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