Cetylpyridinium Nasal Spray Status As Category I Oral Antiseptic Requested
This article was originally published in The Tan Sheet
Executive Summary
Inclusion of a nasal spray containing .05% cetylpyridinium chloride in FDA's tentative final monograph for Oral Antiseptic Drug Products is requested by SinoFresh Research Labs in a March 24 citizen petition
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Nasal spray monograph petition denied
FDA rejects a petition submitted by SinoFresh Research Labs to include nasal sprays containing .05% cetylpyridinium chloride in the tentative final monograph for Oral Antiseptic Drug Products. The agency panel did not consider nasal antiseptics when it evaluated OTC oral antiseptics, FDA states. Consequently, the firm's nasal and sinus care product is an unapproved new drug due to insufficient marketing history. The agency also concludes safety and efficacy data provided by the Venice, Fla. firm is inadequate. SinoFresh petitioned to reopen the administrative record for the monograph to allow for additional data in March 2003 1("The Tan Sheet" April 7, 2003, p. 7)...
Nasal spray monograph petition denied
FDA rejects a petition submitted by SinoFresh Research Labs to include nasal sprays containing .05% cetylpyridinium chloride in the tentative final monograph for Oral Antiseptic Drug Products. The agency panel did not consider nasal antiseptics when it evaluated OTC oral antiseptics, FDA states. Consequently, the firm's nasal and sinus care product is an unapproved new drug due to insufficient marketing history. The agency also concludes safety and efficacy data provided by the Venice, Fla. firm is inadequate. SinoFresh petitioned to reopen the administrative record for the monograph to allow for additional data in March 2003 1("The Tan Sheet" April 7, 2003, p. 7)...
Nasal spray monograph petition denied
FDA rejects a petition submitted by SinoFresh Research Labs to include nasal sprays containing .05% cetylpyridinium chloride in the tentative final monograph for Oral Antiseptic Drug Products. The agency panel did not consider nasal antiseptics when it evaluated OTC oral antiseptics, FDA states. Consequently, the firm's nasal and sinus care product is an unapproved new drug due to insufficient marketing history. The agency also concludes safety and efficacy data provided by the Venice, Fla. firm is inadequate. SinoFresh petitioned to reopen the administrative record for the monograph to allow for additional data in March 2003 1("The Tan Sheet" April 7, 2003, p. 7)...