Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine
Agency IQ
SEPTEMBER 15, 2023
The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.
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