FDA Approvals of 2012

22 of 39


Drug: Xtandi
Generic molecule: enzalutamide
Company: Medivation
Approval date: Aug. 31

The scoop: The drug won an OK a full three months ahead of the FDA's PDUFA date. Astellas is partnered on the program. With a yearly price tag of about $90,000, analysts say peak sales could range from $1 billion to $2 billion. It is approved for post-chemo, castration-resistant patients. But Medivation ($MDVN) hopes to win the same kind of upstream pre-chemo use that Zytiga from Johnson & Johnson just received, an indication that analysts say could double the drug's sales.