FDA actions in brief, June 2007

Key Points

Zoledronic acid (Reclast, Novartis) was approved for the treatment of patients with Paget's disease of the bone.

Antihemophilic factor/von Willebrand factor complex (Humate-P, CSL Behring) was approved for the prevention of excessive bleeding in patients with von Willebrand disease who are undergoing surgery. This agent was previously approved to treat and prevent bleeding in patients with hemophilia A and to treat spontaneous and traumatic bleeding in patients with severe von Willebrand disease and in patients with mild-to-moderate von Willebrand disease when desmopressin use is known or suspected to be inadequate.

Dalteparin injection (Fragmin, Eisai/Pfizer) was approved for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis and/or pulmonary embolism) to reduce the recurrence of VTE in patients with cancer. This agent was previously approved for the prevention of deep vein thrombosis in patients undergoing hip replacement surgery, in at-risk patients undergoing abdominal surgery, and in at-risk acutely ill patients whose mobility is severely restricted. The agent is also approved for prophylaxis of ischemic complications resulting from unstable angina and non-Q-wave myocardial infarction, when used with aspirin.

Gemifloxacin (Factive, Oscient) was approved for the 5-day treatment of community-acquired pneumonia of mild-to-moderate severity. This agent was previously approved for the 7-day treatment of community-acquired pneumonia and for the 5-day treatment of acute bacterial exacerbations of chronic bronchitis.

Paliperidone (Invega, Janssen) was approved for the long-term maintenance treatment of schizophrenia. The agent was previously approved for the short-term treatment of schizophrenia.

Fluticasone nasal spray (Veramyst, GlaxoSmithKline) was approved for the treatment of seasonal and year-round allergy symptoms in adults and children aged ≥2 years.

A once-yearly subcutaneous implant containing histrelin (Supprelin-LA, Indevus) was approved for the treatment of central precocious puberty.

The labeling for abatacept (Orencia, Bristol-Myers Squibb) was updated to change the agent's approved indication. Previously, this agent was approved for slowing the progression of structural joint damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to ≥1 disease-modifying, anti-rheumatic drugs. The agent is now approved for inhibiting the progression of structural joint damage in these patients.

A prefilled disposable insulin pen (Lantus SoloStar, Sanofi-Aventis) was approved for the once-daily treatment of hyperglycemia in patients with type 1 or type 2 diabetes.

A new dosage strength of alendronate/cholecalciferol (Fosamax, Merck) was approved for the treatment of osteoporosis in postmenopausal women. The new strength contains alendronate 70 mg and cholecalciferol (vitamin D₃) 5,600 IU.

A new 10-mg tablet formulation of morphine extended-release (Kadian, Alpharma) was approved for the management of moderate-to-severe chronic pain.

FDA has granted full approval for cytarabine liposome injection (DepoCyt, Enzon) for the treatment of patients with lymphomatous meningitis. This agent was previously granted accelerated approval.