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FDA actions in brief, April 2008


Recent FDA approvals and indications (through April 2008) related to Xyntha, Simcor, Aloxl, Humira, Abilify, Avastin, Nexium, and Luvox.

Antihemophilic factor (recombinant), plasma/albumin-free (Xyntha, Wyeth) was approved for the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A.

A combination of niacin extended-release and simvastatin (Simcor, Abbott) was approved for use along with diet to lower levels of elevated total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, and to raise high-density lipoprotein (HDL) cholesterol levels in patients with complex lipid disease when treatment with simvastatin or niacin extended-release monotherapies are not considered adequate.

Palonosetron (Aloxi, Eisai) was approved for the prevention of postoperative nausea and vomiting for up to 24 hours after surgery.

Bevacizumab (Avastin, Genentech) was approved for use in combination with paclitaxel chemotherapy for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer.

Esomeprazole delayed-release capsules and an oral suspension (Nexium, AstraZeneca) were approved for short-term use in children aged 1 to 11 years for the treatment of gastroesophageal reflux disease (GERD).

An extended-release capsule formulation of fluvoxamine (Luvox CR, Jazz) was approved for the treatment of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD) in adults.

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