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Imprese · 22/12/20051 min di lettura
Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →