FDA's Busy Holiday Season Ends a Busy Year

At the end of a year in which the FDA approved more drugs than it had in any of the previous 15, the agency approved a few more and expanded the age indication for oseltamivir.

The agency approved use of oseltamivir (marketed as Tamiflu) in children as young as 2 weeks old who have shown flu symptoms for 2 days or less.

The oral anticoagulant apixaban (Eliquis) has been approved to reduce risks for stroke and systemic embolism in patients with atrial fibrillation not caused by heart valve problems. The drug's anticoagulant effect is not reversible, and so bleeding is a serious risk with the drug.

Also approved: an antidiarrheal agent, crofelemer (Fulyzaq), to counteract the side effects of antiretroviral therapy in patients with HIV/AIDS.

Finally, bedaquiline (Sirturo) received approval as part of combination therapy to treat multi-drug resistant tuberculosis. Fast-tracked by the FDA, the drug will carry a boxed warning about QT prolongation.