CIMETIDINE, FAMOTIDINE PROPOSED FOR OTC STATUS IN THE U.K.
This article was originally published in The Tan Sheet
CIMETIDINE, FAMOTIDINE PROPOSED FOR OTC STATUS IN THE U.K. by the Medicines Control Agency of the Department of Health, according to a July 6 memorandum asking "interested organizations" to comment on the proposal. Cimetidine is proposed for over-the- counter use for the "short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, provided that the maximum dose of cimetidine is 200 mg, the maximum daily dose of cimetidine is 800 mg and the maximum treatment period is two weeks," the memo says. A second OTC cimetidine indication proposed by the U.K. agency provides for the "prophylactic management of nocturnal heartburn when taken as a single nighttime dose of 100 mg for a treatment period not exceeding two weeks." SmithKline Beecham's Rx-to-OTC switch application in the U.S. for cimetidine, marketed as prescription anti-ulcer remedy Tagamet, is expected to be reviewed in September by a joint meeting of FDA's Nonprescription Drugs Advisory Committee and Gastrointestinal Drugs Advisory Committee ("The Tan Sheet" May 31, p. 1). J&J-Merck's famotidine, which Merck markets as a prescription drug under the tradename Pepcid, is proposed for OTC status by the U.K. agency for the "short-term symptomatic relief of heartburn, dyspepsia and hyperacidity, provided that the maximum dose of famotidine is 10 mg, the maximum daily dose of famotidine is 20 mg and the maximum treatment period is two weeks." In the U.S., J&J- Merck's switch effort for famotidine appears to be lagging behind cimetidine; famotidine is not expected to be reviewed by the FDA committees in September. Famotidine and cimetidine are just two of 11 OTC switches proposed by the Medicines Control Agency, which said it expects the proposals to be implemented by the end of the year "subject to the comments received in consultation, the views of Ministers, and to the appropriate Parliamentary procedure," the July 6 memo says. The comment period ends Aug. 31. Beclomethasone diproprionate, an inhaled steriod that is marketed by prescription only as Schering's Vanceril and Glaxo's Beclovent, also is proposed for OTC status. The proposed switch for beclomethasone is for the treatment of "seasonal allergic rhinitis (hay fever) in adults and children over 12." The proposed non-aerosol nasal dose is 100 mcg per nostril with a maximum daily dose of 200 mcg per nostril. The U.K. agency also recommended that the package size be limited to "a maximum 200 doses." Mebendazole, marketed in the U.S. by Jannsen as the Rx anthelmintic Vermox, is another proposed switch. The proposal covers the treatment of enterobiasis. Versions of mebendazole eligible for OTC status include a "multiple-dose family pack containing not much more than four doses each of 100 mg each for the single-dose treatment of different individual members over the age of two years in a family," the memo states. The U.K. agency recommends that two-dose packs contain "not more than 100 mg mebendazole per dose for the repeated treatment of an individual over the age of two years" and that each dose "be taken at least 14 days apart." Controlled-release pseudoephedrine with a "maximum dose of 90 mg and a maximum daily dose of 180 mg" was another proposed swicth to nonprescription status. Other forms of pseudoephedrine in lower dosage ranges are already available without a prescription in the U.K. Prescription antifungal agent tioconazole, sold in the U.S. by Bristol-Myers Squibb under the tradename Vagistat-1, was proposed by the U.K. agency for OTC use as a vaginal yeast infection treatment. Nonprescription tioconazole has been allowed in the U.K. for external (not vaginal) application. Marion Merrell Dow's Nicorette Plus smoking deterrent chewing gum 4 mg was also proposed for OTC availability. Nicorette 2 mg has been allowed in the U.K. without a prescription since 1991. Other prescription ingredients that are listed for switch to over-the-counter status in the U.K. include: sodium cromoglycate for the treatment of acute seasonal (allergic) conjunctivitis not exceeding 2% weight/volume in aqueous eye drop form, and not exceeding 4% weight/weight in eye ointment form; corlan pellets, each containing 2.5 mg hydrocortisone, for the treatment of aphthous mouth ulcers; other topical hydrocortisone creams and ointments for the treatment of irritant dermatitis, contact dermatitis and/or insect bite reactions that were not covered in an earlier switch; and anhydrol forte.
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