WASHINGTON Wyeth has received a second approvable letter from the Food and Drug Administration for its drug Viviant, which is being studied to prevent osteoporosis. The first Viviant approvable letter asked for more data on bone fractures.
The FDA is seeking additional safety information regarding the incidence of stroke and venous thrombotic events, like deep vein thrombosis, in trials. The agency also highlighted issues about data collection from a clinical study site in Latin America, Wyeth said.
Despite concerns the FDA has with the Viviant application, additional studies were not requested by the agency.