FDA Actions in Brief November 2011 (Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox)

November 1, 2011

Recent FDA Approvals (through October 2011) related to Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox

Rivaroxaban (Xarelto, Janssen Pharmaceuticals), a once-daily, oral anticoagulant, was approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Xarelto is the only oral anticoagulant approved in the United States that offers once-daily dosing, without the need for routine blood monitoring.

Ipratropium bromide and albuterol (Combivent Respimat Inhalation Spray, Boehringer Ingelheim) was approved for the treatment of chronic obstructive pulmonary disease.

FDA has approved bupivacaine liposome injectable suspension (Exparel, Pacira Pharmaceuticals) 1.3% for administration into the surgical site to produce postsurgical analgesia.

Clobazam (Onfi, Lundbeck and Catalent Pharma Solutions) was approved as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older.

A longer duration efficacy and safety for 1% sodium hyaluronate (Euflexxa, Ferring Pharmaceuticals) was approved for the relief of osteoarthritis knee pain. The new labeling supplement provides 26-week efficacy data from the FLEXX trial, as well as 52-week safety data to demonstrate the safety of repeated injection cycles.

Tadalafil (Cialis, Eli Lilly) tablets for once-daily use were approved for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.

Clindamycin Injection (Sagent Pharmaceuticals) was approved for the treatment of bacterial infections caused by susceptible anaerobic bacteria.

Deferiprone (Ferriprox, ApoPharma) was approved to treat patients with iron overload resulting from blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to previous chelation therapy.