FDA AMENDS FINAL RULE ON OTC NASAL DECONGESTANTS

The FDA is amending the final monograph for OTC nasal decongestant drugs to add phenylephrine bitartrate (PEB), both individually and in combination drug products in an effervescent dosage form, as generally recognized as safe and effective.

The final rule, released as part of the FDA's ongoing review of OTC drug products and published in the Aug. 1 Federal Register, allows PEB to be added in an effervescent form as a single ingredient or in combination with aspirin and chlorpheniramine maleate. An effervescent dosage form is dissolved in water before taking orally.

The FDA's amendments to the final rule include changing the definition of "effervescent tablet" to "effervescent dosage form." In conjunction with this change, the agency changed the active ingredient from "phenylephrine bitartrate in an effervescent tablet" to "phenylephrine bitartrate in an effervescent dosage form." The agency had earlier changed the proposed label for this product, removing sinusitis as a permitted indication.

The Federal Register notice is available at www.fda.gov/OHRMS/DOCKETS/98fr/cd0581.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0581.pdf).