Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine
Agency IQ
SEPTEMBER 15, 2023
In 2006, the FDA amended its final rule to add phenylephrine bitartrate (an effervescent formulation) to phenylephrine hydrochloride as GRASE over-the-counter nasal decongestant products included in that final monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments.
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