WASHINGTON (dpa-AFX) - Monday, Viatris Inc. (VTRS) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for MR-107A-02 for the treatment of moderate-to-severe acute pain.
The agency has assigned a PDUFA goal date of December 27, 2026.
The approval is based on data from the Phase 3 program, which includes two randomized, double-blind, placebo- and active-controlled trials - one following herniorrhaphy surgery and one following bunionectomy surgery.
In both studies, fast-acting meloxicam met primary and secondary endpoints and demonstrated a safety profile consistent with the well-characterized safety profile of this mechanism of action.
In the pre-market hours, VTRS is trading at $16.44, down 0.24 percent on the Nasdaq.
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