Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine
Agency IQ
SEPTEMBER 15, 2023
Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Overall, 2022 phenylephrine retail sales reached $1.8 billion, compared with retail sales of $0.5 billion for pseudoephedrine.
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