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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog: Biosimilars

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order. a); OTC Monograph M012: § M012.20.