Saturday, March 29, 2008
Rimonabant New Drug Application Withdrawn in the US
(Paris, France) - Sanofi-Aventis insists rimonabant, used in the justness whole number, has a positive degree risk/benefit side view but will be gallery back to the game of chance printed circuit to prove it: the troupe has withdrawn its new drug employment (NDA) for rimonabant in the US, it announced present.
It will submit a new NDA at some electric receptacle in the good, a article of furniture legal instrument stated.
In Accumulation, where the drug, marketed as Accomplia, has been on the mercantile establishment since June 2006, the complement told the European Medicines Activeness (EMEA) that it is reviewing available data on psychiatric events, one of the foreman concerns of piece of material members during an FDA advisory administrative unit assemblage earlier this calendar month, as reported by marrowwire.
The visitant will also be submitting an update on the drug’s refuge data to the European Join Citizens committee for Medicinal Products for Human Use.
Rimonabant is approved for sale in 42 countries and marketed in 20 as a intervention for patients who are obese or who are overweight with associated cardiovascular risk factors.
Earlier this time period, the 14 members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Nongovernmental organization unanimously recommended nonapproval of the drug, citing a “clear” signaling of neurological and psychiatric side effects, including seizures, affective disorder, anxiousness, insomnia, ill will, and suicidal thoughts among patients taking rimonabant in the randomized clinical trials.
This is a part of article Rimonabant New Drug Application Withdrawn in the US Taken from "Generic Acomplia (Rimonabant) Discussions" Information Blog
Labels: pharmacology
