The accompanying table [click to enlarge image] presents an updated calendar of expected FDA decision dates, including a new NDA filing by Johnson & Johnson (JNJ) for Comfyde and recent approval for Barr Pharma's (BRL) low-dose birth control pill Lo-Seasonique. Teva Pharma (TEVA) has closed a deal with Barr's unsecured credit holders in an effort to close its proposed $7.5B acquisition by year-end, which will expand Teva's generic drug business and also add to its line-up of brand name medications through Barr's strong presence in birth control. Another new filing includes Northfield Lab's BLA for the hemoglobin-based blood substitue PolyHeme, with an expected ruling by the FDA on 12/28/08 as to whether they will accept the application and rule on it within six months as a priority review -- which would result in a final decision as early as 4/28/09.
$61.01 (10/30/08)
