Reloxin - receives FDA approval today

Botox competitor "Reloxin" (sold in Europe as "Dysport") received its FDA approval today.

The FDA decided to approve both the cosmetic indications (for wrinkles) and the functional indications (cervical dystonia) at the same time - and decided that the drug should be sold under the same name for both categories. So, it's now officially "Dysport" - just like in Europe.

We're waiting for details to be released about the pricing, marketing incentives - such as potential combinations with Medicis' line of fillers, and so forth. These details will be key to the success or failure of the product, I believe.

The next 6 months should prove to be very interesting, to see how pharma giant Allergan responds to the "new kid on the block". I'm expecting sparks to fly!!

Reloxin - a potential challenger to Botox Cosmetic?

"Reloxin", a form of botulinum toxin, and potential competition for Botox, could go on sale in the U.S. soon.

The FDA is currently evaluating the product, which has been sold in Europe for approximately 15 years under the name Dysport. It's a wrinkle-fighter, similar to Botox, and it also has a good track record of success and a good record of safe use.

Medicis, the U.S. distributor, said it is hoping for FDA approval of their application in early 2009.

It will be interesting to see how this situation works out. Will the newcomer try to under-cut the price of Botox? Will patients be willing to try the newcomer, or stick with the original? The dosing of Dysport and Botox is not directly comparable - so it wouldn't be a simple 1:1 substitution - but both have been shown to be effective for dynamic facial wrinkles.

Botox, made by Allergan, has been the No. 1 cosmetic medical treatment in the United States for the last few years, according to the American Society for Aesthetic Plastic Surgery (ASAPS) procedural statistics.