The year to come
Here are the notable upcoming FDA decisions in 2008 for selected drug developers' top compounds:
Developer | Drug | Potential Indication | History | Review Date |
|---|---|---|---|---|
Elan and Biogen IDEC (Nasdaq: BIIB) | Tysabri | Crohn's disease | Positive FDA advisory panel | Jan. 13 |
Cardiome | Intravenous Vernakalant | Acute atrial fibrillation | Two positive phase 3 trials | Jan. 19 |
Adolor (Nasdaq: ADLR) and GlaxoSmithKline | Entereg | Postoperative ileus | Multiple approvable letters | Feb. 10 |
Genentech (NYSE: DNA) | Avastin | Front-line late-stage breast cancer | FDA request for new data in 2006 | Feb. 23 |
QLT | Aczone | Less restrictive label for acne | Approved in 2005. Not marketed due to label restrictions | March 23 |
Discovery Labs (Nasdaq: DSCO) | Surfaxin | Respiratory distress syndrome in premature infants | Multiple approvable letters | May 1 |
CV Therapeutics (Nasdaq: CVTX) | Ranexa | Front-line angina and diabetes | Positive phase 3 trial | July 27 |
Vanda Pharmaceuticals (Nasdaq: VNDA) | Iloperidone | Schizophrenia | Multiple phase 3 studies | July 27* |
