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Mylan generic glyburide distribution is halted as negotiations with Mova fail.

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Executive Summary

MYLAN GENERIC GLYBURIDE DISTRIBUTION HALTED AS NEGOTIATIONS WITH MOVA FAIL, prompting implementation of D.C. Federal Court Judge James Robertson's preliminary injunction rescinding FDA approval of Mylan's micronized glyburide. Judge Robertson ruled against FDA Jan. 23 in Mova's suit protesting the Dec. 19 approval of Mylan's ANDA for the generic version on Pharmacia & Upjohn's Glynase. Mova's micronized glyburide ANDA, filed in December 1994, is the subject of patent litigation brought by Upjohn in Puerto Rico federal court. Mylan stopped distributing micronized glyburide on Jan. 15; a recall will not be instituted.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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