Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
The product is backed by required scientific proof and comparative bioequivalence studies
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