FDA Approvals of 2012

33 of 39


Drug: Iclusig
Generic molecule: ponatinib
Company: Ariad Pharmaceuticals
Approval Date: Dec. 14

The scoop: The FDA announced it had approved ponatinib to treat two types of leukemia a full three months before the drug's PDUFA date. The drug, selected as a blockbuster hopeful by analysts, will be sold at a wholesale acquisition cost of $9,580 a month, or $115,000 a year, according to CEO Harvey Berger in a call with analysts following approval. FierceBiotech featured ponatinib as one of the 10 cancer drugs in late-stage development to watch this year.