By Alexander Pahlavi
With an overwhelming vote, an FDA advisory committee recently recommended against approving Charleston Laboratories’ Hydexor, a fixed-dose combination drug containing hydrocodone (HC), acetaminophen and promethazine.
Coupled with concern over another opioid-based drug on the market with potential for misuse and abuse, the applicant failed to sufficiently convince the committee that its product’s efficacy in reducing opioid-induced nausea and vomiting (OINV)