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.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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