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Executive Summary

LEMMON's CLEMASTINE FUMARATE IS FIRST GENERIC form of Sandoz' prescription antihistamine products Tavist-1 (1.34 mg tabs) and Tavist (2.68 mg tabs) approved by FDA. Clemastine, approved on Jan. 31, is Lemmon's second ANDA to be cleared by FDA within the last few weeks. The company received the first generic approval of the topical antibiotic fluocinonide ointment (Syntex' Lidex) on Dec. 27. Lemmon's most recent ANDA approval before fluocinonide and clemastine was "nearly two years" ago, the firm's parent corporation, Teva Pharmaceutical, noted in a Feb. 3 press release. Lemmon's two-year wait for ANDA approvals must have been particularly trying for a company that has made bold predictions about its pipeline. In November 1990, in the midst of the generic drug scandal, Lemmon parent Teva told a meeting of securities analysts in New York that it anticipated receiving approval of generic sucralfate, having filed an ANDA for sucralfate in 1989 and undergone a preapproval inspection during the summer of 1990. Sandoz' Tavist line accounted for an estimated $115 mil. in sales in 1990. However, the long-acting antihistamine/decongestant combination Tavist-D (clemastine/phenylpropanolamine) alone accounted for about $75 mil. of the total sales of the line. The February 1992 issue of American Druggist ranks Tavist-D as the 76th most frequently dispensed prescription drug in 1991. The Tavist-D patent is due to expire on Jan. 20, 1993. Sandoz' clemastine patent expired July 9, 1980. The appearance of a generic clemastine may increase pressure on Sandoz to transfer Tavist-D to OTC status to head off further erosion of the line's sales. The firm told securities analysts last year that it is planning an Rx-to-OTC switch for the combination product ("The Pink Sheet" Dec. 23, p. 5). Introduction of multiple brands of nonsedating antihistamines -- particularly those combined with decongestant ingredients, like Marion Merrell Dow's Seldane-D -- already have eaten into the Tavist-D market. MMD told analysts late last year that Seldane-D required only six weeks of U.S. marketing to surpass Tavist-D as the leading prescription allergy product ("The Pink Sheet" Dec. 9, p. 13). FDA denied an Rx-to-OTC switch for Tavist-1 in 1985 due to an unsubstantiated low drowsiness claim. The agency required Sandoz to submit comparative data on drowsiness associated with antihistamines before permitting a low drowsiness claim for Tavist-1. The situation was exacerbated in 1987 when FDA and Capitol Hill objected to a full-page open letter from Sandoz to prescribers that was published in newspapers and described Tavist- 1's "low drowsiness."

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