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

CIBA-GEIGY's HABITROL TRANSDERMAL NICOTINE PATCH APPROVED

Executive Summary

CIBA-GEIGY's HABITROL TRANSDERMAL NICOTINE PATCH APPROVED by FDA on Nov. 27, making it the second transdermal nicotine smoking- cessation patch to clear the agency. With the launch of Alza/Marion Merrell Dow's 24-hour Nicoderm patch potentially grounded by a preliminary injunction, Habitrol could be the first nicotine patch to reach the U.S. market (see following T&G). The 24-hour patch was given a "3C" rating (a new formulation representing no therapeutic gain). The Habitrol NDA had been pending at FDA since November 1990. The NDA was deemed "approvable" on Nov. 7, 1991 ("The Pink Sheet" Nov. 11, T&G-1). Ciba-Geigy said that Habitrol will be in pharmacies across the country by the week of Dec. 23. Approximately 1,000 of Ciba- Geigy's U.S. salespeople will detail the patch to doctors and hospitals. Habitrol treatment usually lasts "up to three months, during which time the dosage of nicotine is gradually reduced" Ciba-Geigy said. Like Nicoderm, Habitrol comes in three strengths: 21 mg, 14 mg, and 7 mg of nicotine per 24 hours. According to the company, "most smokers will be prescribed the largest patch first . . . and will be weaned from nicotine addiction with the smaller patches." Habitrol's price will be approximately $ 3 per day, the company said. In addition to the nicotine patches, patients prescribed Habitrol also will receive the "Habitrol Smoking Cessation Program," which includes a collection of "behavioral support information" and an audiotape from the American Lung Association "to reduce stress and provide motivation." Physicians will receive an "office support kit" with information on how to help smokers quit.

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

LL1133833

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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