Sanofi-Aventis’ Diet
drug Acomplia (rimonabant) is getting quite
good responses at Indian pharmacies. According to reports
from the Indian media, Acomplia in generic form is being
sold without a prescription for as little as 12 cents.
Sanofi received approval to sell Acomplia
in India in May, the same month as the generic-drug makers.
The company hasn't decided whether to sell its branded version
there. ``We're evaluating our options,'' Podvin said. ``Of
course, it's a concern''.
While sales of so-called "generic rimonabant"
are entirely legal in India, where pharmaceutical manufacturers
are allowed to produce reverse-engineered versions of drugs
patented before 1995, sale of these Indian versions of rimonabant
would not be legal in the U.S., Europe or Canada.
A half-dozen pharmaceutical companies -- including such
well-regarded generic drug manufacturers as Ranbaxy and
Cipla -- received approval from Indian regulatory authorities
in May to sell their own versions of rimonabant.
Acomplia- sold in Europe for more than $100 per month-
is still awaiting for approval for sale in the United States.
Some doctors are worried that the depressive side-effects
of rimonabant -- which led an FDA advisory panel to recommend
that Acomplia not be approved for sale
in the U.S. -- may be cause for increased concern if large
numbers of Americans take rimonabant without medical supervision.
"This is going to be potentially disastrous,'' Dr. Jeffrey Mechanik, an endocrinologist at Mt. Sinai Hospital in New York, told Bloomberg News."People are going to be over-dosing'' if generics flood the market and people take them inappropriately.