Source Pravda.Ru

Wyeth's bazedoxifene gets 3d approvable letter

One of the largest pharmaceutical companies in the world Wyeth Pharmaceuticals has received the FDA’s third approvable letter for its innovation – bazedoxifene.

Bazedoxifene is a selective estrogen receptor modulator (SERM) developed for the prevention and treatment of postmenopausal osteoporosis. It is currently in the last phase of review by the United States' Food and Drug Administration that points at some issues that must be resolved before the FDA will grant final approval to a new drug candidate.

When approved, bazedoxifene is to be sold by Wyeth under the tradename Viviant.

Wyeth received the first approvable letter for Bazedoxifene in late April 2007. The FDA called for final safety and efficacy data from Phase III studies, and acceptable valuation of manufacturing and testing facilities where problems were found earlier in the year. The second letter was received in December.

The FDA is still concerned about potential risks of stroke and blood clots, thus requesting additional trials and data collection.

Photo: www.ams.org

Comments
Russian poultry stuffed with antibiotics and dangerous bacteria
Americans declassify plans to drop 466 nuclear bombs on USSR
Russia's new torpedo carrying 100-megaton nuclear warhead nullifies USA's Prompt Global Strike
Russia's and China's gold may end global domination of US dollar
Unveiled: Secret Pentagon UFO program. From science fiction to science fact
Russian poultry stuffed with antibiotics and dangerous bacteria
Russia eyes opportunity to restore all Soviet bases that had to be abandoned after 1991
Call girl dies of asphyxia in bizarre sexual encounter
Call girl dies of asphyxia in bizarre sexual encounter
Call girl dies of asphyxia in bizarre sexual encounter
German experts name Russia's most dangerous weapon
Russia to impose sanctions on WADA for Winter Olympics 2018
Russian Guard to see enemies behind walls
What will happen if USA freezes Russian dollar assets?
Ukraine suspicious about Russia's intention to give away rusty ships to Kiev
Russian Armed Forces to receive second-to-none gliding bomb
Euro-Islam: New religion to break migrants in EU
Euro-Islam: New religion to break migrants in EU
Euro-Islam: New religion to break migrants in EU
Euro-Islam: New religion to break migrants in EU
Turkey distances itself from Russia to plunge Syria into greater chaos