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April 28, 2009

Reloxin: When?

The FDA had previously delayed the release of Reloxin, a Botox analog, because of administrative issues. Medicis, the US company that will be distributing Reloxin, had filed additional paperwork with the FDA detailing its plan for follow up of adverse events. The FDA was supposed to give Medicis an answer this month, but there has been no announcement forthcoming. The reasons are unclear, at this point.

There is no question that Reloxin will be approved. It has a long and successful track record in Europe and Canada. Reloxin may have some advantages over Botox. It has an earlier onset of activity and may, depending on the dosage, last longer than Botox. Reloxin may also spread more widely than Botox, and there will be a learning curve as physicians begin to use it. However, it seems clear that the public will be the looser as a result of the delay. It has not served people well to have a single company maintain a long term monopoly on Botulinum Toxin Type  A. Competition should lower prices and enable each product to find its optimum use.
Additional Botox-like products are in the pipeline and, in my view, more choice will be even better.

Gerald N Bock MD
California Skin & Laser Center
Stockton & Lodi, CA

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