FDA actions in brief, March 2010 (Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor)


Recent FDA approvals (through March 2010) related to Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor.

Desirudin for injection (Iprivask, Canyon) was approved for the prevention of deep vein thrombosis.

Velaglucerase alfa for injection (VPRIV, Shire) was approved for the long-term treatment of type 1 Gaucher disease in pediatric and adult patients.

Pramipexole dihydrochloride extended-release tablets (Mirapex ER, Boehringer Ingelheim) was approved for the signs and symptoms of early idiopathic Parkinson's disease.

Meningococcal oligosaccharide diptheria CRM197 conjugate vaccine (Menveo, Novartis), a quadrivalent meningococcal conjugate vaccine, was approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in people aged 11 to 55 years.

Lamotrigine extended-release tablets (Lamictal XR, GlaxoSmithKline) was approved as a once-daily, add-on therapy for epilepsy patients 13 years of age or older with partial onset seizures.

Rituximab (Rituxan, Genentech/Roche, Biogen Idec) was approved in combination with fludarabine and cyclophosphamide for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia.

Trazodone hydrochloride extended-release tablets (Oleptro, Labopharm) was approved as a once-daily formulation of trazodone for the treatment of major depressive disorder in adults.

Collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) was approved for the treatment of adult Dupuytren's contracture.

A heat-stable version of ritonavir (Norvir, Abbott Laboratories) was approved for the treatment of HIV treatment.

Olmesartan medoxomil (Benicar, Daiichi Sankyo) was approved to treat hypertension in children and adolescents aged 6 to 16 years.

Rosuvastatin calcium (Crestor, AstraZeneca) was approved for wider use to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease.

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