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Roche/GSK delay Boniva launch

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Launch of Roche/GlaxoSmithKline's osteoporosis agent Boniva (formerly Bonviva) will await approval of a less frequent dosing regimen. Ibandronate was approved May 16 as a once-daily 2.5 mg tab. "for the treatment and prevention of osteoporosis in postmenopausal women." Roche says the "submission will be supplemented at the earliest possible opportunity, following the completion of ongoing Phase III clinical trials." Merck's Fosamax (alendronate) and Procter & Gamble's Actonel (risedronate) are both available as once-weekly regimens. Boniva approval was based on studies in women with postmenopausal osteoporosis demonstrating reductions in the incidence of new vertebral and non-vertebral fractures and improvement in bone mineral density...
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