FDA Approvals of 2012

39 of 39


Drug: Sirturo
Generic molecule: bedaquiline
Company: Johnson & Johnson
Approval date: December 31

The scoop: The FDA made history on the last day of 2012 as the agency approved for the first time in forty years a new treatment for tuberculosis. From Johnson & Johnson's ($JNJ) Janssen Therapeutics unit, Sirturo was approved for use in patients with "multidrug resistant pulmonary tuberculosis (TB) when other alternatives are not available." Given a fast-track designation despite a warning concerning potentially fatal abnormal hearth rhythms, Sirturo is considered a "much-needed treatment for patients who don't have other therapeutic options available."