 |
|
 |
 |
|
||||||||||||||
|
Moderate Chances for Acomplia to Be Marketed As Zimulti June 19, 2007 Foreseeing June 13 fiasco, it seems that the French drug maker Sanofi-Aventis's long cherished desire to promote terrific rimonabant as Zimulti is probably not going to be true. So, Americans will not have to wait any more. Leaving aside the possibility of a marvel, it is almost sure that rimonabant will not be permitted by the FDA to be sold in the U.S. for nearly next two to three years. Being not deterred by the debacle, the drug maker will still persist to sell rimonabant in Europe, the Middle East, Latin America, Mexico and all other nations, wherein the wonderful weight-loss drug is either available on sale or awaiting to be launched. Right from the beginning, Sanofi was never pleased with the idea of change in drug's name. It was the FDA who posed hindrance in the way of Paris-based drug maker and forced it to change the name Acomplia to rather an odd name Zimulti. The FDA then made it obvious that it would not allow Sanofi to be sold with the same name Acomplia, which in its view, was too indicative that the drug would allow overweight to "acomplish" their respective weight loss targets. Though Sanofi agreed to change name and somehow managed to come up with a novel name Zimulti for the United States, yet the report of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on June 13th discarded the drug and made it explicit how the maker absolutely misinterpreted the intensity of FDA's staff concerns over the safety of Acomplia. With the uncertainty of new trials to proffer the kind of safety data required by the agency till the prologue of large CRESCENDO study, which would be conducted on 17,000 participants, the likelihood of the FDA providing approval to Zimulti quite earlier on the basis of few interim analysis seems extremely blur. Thus, if you are roving in and around Mexico, Caribbean islands,
or Europe this sizzling summer and keen to try rimonabant, do remember
that the name of the drug you are looking for is Acomplia, not Zimulti.
|
||||||||||||||
