FDA reviews Reloxin for U.S. use

Scottsdale, Ariz. - Medicis Pharmaceutical, based here, has announced that the Food and Drug Administration (FDA) has begun a review of Reloxin, the company’s Botox-like anti-wrinkle injectable, the Arizona Republic reports.

In March, the FDA accepted an application filed by Medicis and its European partner, Ipsen, requesting approval to sell Reloxin as an aesthetic drug in the United States. The botulinum-toxin product already is approved for aesthetic use in 23 countries.

Under terms of an agreement between the two companies, Medicis will pay Ipsen $25 million based on the FDA review announcement. If the FDA approves Reloxin for aesthetic use, Medicis will pay an additional $75 million to Ipsen for U.S. marketing rights.

Medicis expects Reloxin to be a pivotal part of the company's growing aesthetics business. Medicis already sells Restylane, a hyaluronic acid used to plump up wrinkles and folds.

According to the Republic, Medicis has begun a “significant expansion” of its Scottsdale operations and likely will begin recruiting and training more sales representatives in anticipation of the FDA’s approval of Reloxin, which could come in early 2009.

To date, Allergan’s Botox is the only botulinum-toxin product approved for aesthetic use in the United States.