E. Fougera & Co has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx) for the treatment of acne vulgaris. Fougera’s Adapalene Cream 0.1% is rated AB, generically equivalent to Differin® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.

Galderma, the leading pharmaceutical company in dermatology, and Ipsen, an international innovation-driven specialty pharmaceutical group, announced that Azzalure® (botulinum toxin type A manufactured by Ipsen), has received a marketing authorization in Spain from the Spanish Medicines and Healthcare Products Agency (AEMPS). Azzalure is a local muscle relaxant specifically developed for aesthetic use and has been approved for the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown (vertical lines between the eyebrows), in adult men and women aged up to 65 years, when the severity of these lines has an important psychological impact on the patient.

A new prescription acne gel called Epiduo has been approved by the FDA for patients aged 12 and more. Epiduo is the combination of two drugs, benzoyl peroxide 2.5% and adapalene 0.1%, which are being used as acne treatments since long. Epiduo, manufactured by Galderma, is the once daily drug and is the “first and only” combination acne gel of its kind.