Galderma/Ipsen's Azzalure cleared in France
Galderma, a Swiss dermatology-focused pharmaceutical company, and French drugmaker Ipsen's co-developed Azzalure (botulinum toxin Type A), a muscle relaxant specifically developed for esthetic use, has received marketing authorization in France.
The approval is for the temporary improvement in the appearance of moderate-to-severe glabellar lines seen at the frown, in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact. The approval was based on several clinical trials involving more than 2,600 subjects, which confirmed the safety and efficacy of Azzalure.
Made by Ipsen, the agent will be marketed by Galderma in France before the end of the first half of 2009, and will come in a very easy-to-use formulation with a customized dosage that is specifically designed to better meet the esthetic needs of the patient.
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