Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ALZA/CIBA’s EFIDAC/24 24-HOUR NASAL DECONGESTANT APPROVED

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

ID1132542

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel