Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine
Agency IQ
SEPTEMBER 15, 2023
The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Once metabolized, which occurs quickly with a half-life of approximately 1.5 billion for pseudoephedrine.
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