Bristol-Myers Squibb Vanlev
This article was originally published in Pharmaceutical Approvals Monthly
Enrollment in the ongoing OCTAVE (Omapatrilat Cardiovascular Treatment Assessment Versus Enrollment) hypertension study was completed the week of Jan. 18, with an estimated 25,000 subjects being randomized. The company expects to refile an NDA application for treatment of hypertension after OCTAVE results are available in mid-2001. Bristol withdrew its Vanlev NDA due to FDA concern about the incidence of angioedem
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