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DURA LAUNCHING TORNALATE (BITOLTEROL MESYLATE) BRONCHODILATOR

Executive Summary

DURA LAUNCHING TORNALATE (BITOLTEROL MESYLATE) BRONCHODILATOR six months after approval of the beta agonist on Feb. 19 as a "3S" drug. The San Diego-based asthma and allergy product firm Dura Pharmaceuticals began shipping (bitolterol) .02% solution for nebulization in August. The delay in the product's launch has been due, in part, to labeling and advertising discussions with FDA, the company said. Dura licenses Tornalate from Sterling Winthrop. Dura plans to position Tornalate as a bronchodilator with a longer duration of action than albuterol sulfate. Ads are planned for the October issues of medical specialty journals. Tornalate's duration of action was six or more hours for most patients in clinical trials and eight hours in 40% of the patients studied. By comparison, albuterol inhalation solution labeling states that pulmonary function improvements are seen in some patients up to six hours following treatment. In April, Dura said it planned to launch bitolterol under the trade name Produral ("The Pink Sheet" April 20, p. 2). Dura's 92-person sales force also will market a Tornalate metered-dose inhaler licensed from Sterling Winthrop last June. Both products are being manufactured by Sterling Winthrop; Dura has exclusive rights worldwide except Italy (and Puerto Rico for the MDI). Tornalate was approved six years after Sterling filed the NDA.
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