Monday, September 16, 2013
Although vilanterol looks
poised to pass muster at FDA for a second time, companies working on
products that contain a LABA should not view it as a sign the agency is no
longer requiring companies to establish the lowest effective dose.
FDA last week told BioCentury
it needs to see a well-defined dose-response curve that clearly identifies the
lowest dose on the ascending portion of the curve.