Copies of diet drug Acomplia (rimonabant) are being widely sold at Indian pharmacies without a prescription for as little as $3.60 for a month's supply of the pill, according to reports from the Indian media.
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.
Sanofi-Aventis, developer of Acomplia / Zimulti, also received approval in May to sell its own far-more-expensive diet drug in India, but thus far has not decided whether to put in on the market. Acomplia is sold in Europe for more than $100 per month, but has not been approved for sale in the United States.
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.
However, in the internet age, with Acomplia / Zimulti unlikely to be approved for U.S. sale for at least another two years, pent-up demand for rimonabant by desperate obese and overweight Americans suggests a brisk international mail-order market is likely to develop for the generic products
Already, one off-shore pharmacy is advertising availability of generic rimonabant on one of our sister sites, RimonabantReport.com.
While shipments of drugs not approved for sale in the United States are not supposed to be allowed into the country, many packages slip through.
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.
Beyond the commercial implications of knock-off versions of rimonabant being sold to U.S. customers via the internet for less than what Sanofi hoped to charge for its brand-name drug, a surge in problems linked to rimonabant might well dim prospects that the FDA will ever approve sale of Acomplia.
While Indian regulators approved generic versions of rimonabant as a prescription drug, Indian media reports a number of pharmacies in major cities sell the diet pills without asking for a prescription.
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