Food and Drug Administration

Another New Blood Thinner FDA Approved : Xarelto (Rivaroxaban)

Today the FDA approved Xarelto (Rivaroxaban) for irregular heart beat (= atrial fibrillation = a. fib). The approved dose is 20 mg once daily. The link to the FDA press release is here. The Xarelto prescribing information can be found here. Xarelto for Blood Clots in the Veins (DVT and PE)

November 4, 2011
Rivaroxaban (Xarelto): FDA Advisory Board Recommends Against Approval for Atrial Fibrillation

Surprise to many people today: An FDA staff report released today (Sept 6th, 2011) states that FDA reviewers recommend against the approval of rivaroxaban (Xarelto) for the atrial fibrillation indication. A detailed discussion with reasons for the recommendation can be found here. The main reason: It has not been shown that rivaroxaban is as effective as…

September 6, 2011

Tag: Food and Drug Administration