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In Brief: TAP's Lupron Mist

Executive Summary

TAP's Lupron Mist: Takeda-Abbott Pharmaceuticals files NDA in December for metered-dose leuprolide acetate for endometriosis. Lupron is available in injectable form. In a Dec. 22 petition to FDA requesting permission to use chlorofluorocarbons, TAP asserts that the only other luteinizing hormone releasing hormone in an aqueous form for endometriosis, Syntex' Synarel (nafarelin acetate) nasal spray, "is absorbed erratically, and relief of symptoms is variable." Lupron Mist has greater bioavailability than Synarel, TAP maintains. TAP is developing a CFC-free Lupron product using HFA-134a as a propellant, but the product is not projected to enter Phase I trials until late 1996...
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