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Alza

This article was originally published in The Tan Sheet

Executive Summary

Receives "approvable" letter from FDA on June 30 for chlorpheniramine maleate extended-release 8 mg and 16 mg tablets. The NDA was filed by Alza in September 1987. The 24-hour OTC antihistamine product is based on Alza's OROS controlled-release technology that is also the basis for 24- hour nasal decongestant Efidac/24, marketed by Ciba under a royalty-bearing licensing agreement ("The Tan Sheet" June 28, p. 5). Ciba also will market the controlled-release chlorpheniramine.
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