[e-farmacos] Rimonabant (cont.)

["Caffaratti, Mariana" <cimecord@mail.fcq.unc.edu.ar>]

Estimado Daniel,

En junio de 2006, rimonabant recibio autorizacion de comercializacion para 
el tratamiento de la obesidad en la Union Europea.

Saludos,

Mariana Caffaratti
CIME
Centro de Informacion de Medicamentos
Facultad de Ciencias Quimicas
Universidad Nacional de Cordoba
Http://www.fcq.unc.edu.ar/cime
(Argentina)

The NDA was accepted for review by the FDA on June 23, 2005; in phase III 
development in Europe. On February 20, 2006 the manufacturer reported that 
the FDA issued an approvable letter for rimonabant for weight management but 
a non-approvable letter for smoking cessation. On April 28, 2006 the 
European Union (EU) regulatory agency recommended rimonabant 20 mg PO daily 
(Acomplia®) for approval as an adjunct to diet and exercise for the 
treatment of obese patients (BMI >= 30kg/m2) or overweight patients (BMI > 
27 kg/m2) with associated risk factors, such as type 2 diabetes or 
dyslipidemia. Rimonabant received marketing authorization in the EU in June, 
2006.
http://www.clinicalpharmacology.com/apps/default.asp?entry=11&rNum=293