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Decongestant Monograph Definition Expansion Requested By Bayer

This article was originally published in The Tan Sheet

Executive Summary

FDA should revise its definition of effervescent cold products containing phenylephrine bitartrate (PEB) to make it more flexible, Bayer states in recent comments to FDA

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Phenylephrine bitartrate

The final monograph (FM) for over-the-counter nasal decongestant drug products will include phenylephrine bitartrate (PEB) individually and in combination drug products in an effervescent dosage form, FDA states in a final rule published in the Federal Register Aug. 1. Additionally, FDA is "expanding" the definition of the term "effervescent tablet" that appeared in the proposed rule with the new term "effervescent dosage form." The agency is making the change "to provide greater formulation flexibility to permit other effervescent dosage forms to be marketed....the pharmacokinetic data provided for the PEB effervescent tablet dosage form would also support use of an effervescent granule or powder dosage form," the notice states. The agency also concludes phenylephrine hydrochloride and PEB can be used interchangeably due to similar safety and efficacy profiles. FDA proposed the monograph amendment in November 2004 (1"The Tan Sheet" Nov. 8, 2004, p. 11). Alka-Seltzer marketer Bayer submitted comments supporting the amendment to the monograph in February 2005 (2"The Tan Sheet" Feb. 14, 2005, p. 7)...

Phenylephrine bitartrate

The final monograph (FM) for over-the-counter nasal decongestant drug products will include phenylephrine bitartrate (PEB) individually and in combination drug products in an effervescent dosage form, FDA states in a final rule published in the Federal Register Aug. 1. Additionally, FDA is "expanding" the definition of the term "effervescent tablet" that appeared in the proposed rule with the new term "effervescent dosage form." The agency is making the change "to provide greater formulation flexibility to permit other effervescent dosage forms to be marketed....the pharmacokinetic data provided for the PEB effervescent tablet dosage form would also support use of an effervescent granule or powder dosage form," the notice states. The agency also concludes phenylephrine hydrochloride and PEB can be used interchangeably due to similar safety and efficacy profiles. FDA proposed the monograph amendment in November 2004 (1"The Tan Sheet" Nov. 8, 2004, p. 11). Alka-Seltzer marketer Bayer submitted comments supporting the amendment to the monograph in February 2005 (2"The Tan Sheet" Feb. 14, 2005, p. 7)...

Phenylephrine bitartrate

The final monograph (FM) for over-the-counter nasal decongestant drug products will include phenylephrine bitartrate (PEB) individually and in combination drug products in an effervescent dosage form, FDA states in a final rule published in the Federal Register Aug. 1. Additionally, FDA is "expanding" the definition of the term "effervescent tablet" that appeared in the proposed rule with the new term "effervescent dosage form." The agency is making the change "to provide greater formulation flexibility to permit other effervescent dosage forms to be marketed....the pharmacokinetic data provided for the PEB effervescent tablet dosage form would also support use of an effervescent granule or powder dosage form," the notice states. The agency also concludes phenylephrine hydrochloride and PEB can be used interchangeably due to similar safety and efficacy profiles. FDA proposed the monograph amendment in November 2004 (1"The Tan Sheet" Nov. 8, 2004, p. 11). Alka-Seltzer marketer Bayer submitted comments supporting the amendment to the monograph in February 2005 (2"The Tan Sheet" Feb. 14, 2005, p. 7)...

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