Wyeth withdraws European MA application for Brilence; AstraZeneca to provide more info to US FDA on Axanum
The European Medicines Agency (EMEA) says it has been formally notified by Wyeth Europa (now a part of US drug behemoth Pfizer) of its decision to withdraw its duplicate application for a centralized marketing authorization for Brilence (bazedoxifene), intended to be used for the treatment of osteoporosis in postmenopausal women at increased risk of fracture, 200mg film-coated tablets.
The application for the marketing authorization for Brilence was submitted to the Agency on October 2, 2009. At the time of withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).
In its official letter to the EMEA, the company stated that the reason for the withdrawal of the application was that no co-marketing partner had been identified prior to the CHMP opinion.
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