FDA Approvals of 2012

38 of 39


Drug: Fulyzaq
Generic molecule: Crofelemer
Company: Salix Pharmaceuticals
Approval date: December 31

The scoop: The FDA approved Salix Pharmaceutical's diarrhea drug Fulyzaq for HIV patients on the last day of the year. Derived from the Croton lechleri plant, Fulyzaq is the second botanical drug ever approved by the FDA. Although not expected to be a big earner for Salix with an estimate of only $33 million in 2014, the company ($SLXP) counts on Fulyzaq to broaden its product line.