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Executive Summary

ALZA/CIBA's EFIDAC/24 24-HOUR NASAL DECONGESTANT APPROVED by FDA on Dec. 15, becoming the first over-the-counter 24-hour cold medication available for marketing. Efidac/24 (pseudoephedrine 240 mg tablets) "provides temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and nasal congestion associated with sinusitis," approved package labeling states. Alza submitted an NDA for Efidac/24 in September 1989 and amended it 19 times. Alza will manufacture Efidac/24. Utilizing Alza's OROS osmotic controlled-release technology, Efidac/24 "is a nasal decongestant in a specially formulated one tablet, once daily dosage for all day and all night relief," package labeling states. Each tablet has an outer coating of medication "that is released immediately," labeling reads, and "the tablet continues to work by releasing medication at a precisely controlled rate -- providing relief for a full 24 hours without drowsiness." A 1990 review of the OTC cold products market by POV Reports predicted that "Efidac/24 could have a huge impact on the OTC cold market," adding that "the possibility of all day and all night relief with a single dose is an exciting concept" ("The Pink Sheet" Nov. 26, 1990, T&G-9). Efidac/24 is one of a group of OTC cough/cold/allergy products based on Alza's OROS technology that, once approved, will be marketed in the U.S. by Ciba Consumer Pharmaceuticals under a 1988 royalty-bearing license agreement with Alza ("The Pink Sheet" Oct. 24, 1988, T&G-1). Ciba says it will promote Efidac/24 "aggressively." Other products in development under the deal include a chlorpheniramine product and a brompheniramine/pseudoephedrine combination developed by Alza. OROS-based drugs being developed by Ciba include a pseudoephedrine/brompheniramine combination, another pseudoephedrine product and another chlorpheniramine product. Ciba's Acutrim (phenylpropanolamine) appetite suppressant was the first OROS-based consumer product to reach the market.

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