FDA approves derma drug claim for Sonoma Pharmaceuticals

Petaluma-based Sonoma Pharmaceuticals, Inc. (SNOA), a specialty pharmaceutical company manufacturing dermatological and advanced tissue care solutions announced that it has received Food and Drug Administration (FDA) approval of its expanded antimicrobial claim for the company’s key dermatology gel product, Alevicyn™ SG Antipruritic Spray Gel.

“With this second FDA approval now in hand, we’re pleased that both the Alevicyn Dermal Spray solution and gel products for the management of atopic dermatitis or eczema have expanded claims to include antimicrobial language and data demonstrating effectiveness against clinically relevant organisms,” said Jeff Day, president of Sonoma Pharmaceuticals’ dermatology division, IntraDerm Pharmaceuticals.

The company’s Tuesday announcement stated the product is useful in treating various inflammatory skin dermatoses including atopic dermatitis and eczema, ”without the side effects of topical steroids and resistance issues associated with the overuse of antibiotics.”

Over the last three years, there have been over 61,000 prescriptions filled for the Alevicyn family of products, valued at over $7.5 million. The company stated the global market for skin disease treatment technologies is estimated to reach $20.4 billion in 2020. The U.S. market is the largest segment and should reach $8.6 billion in 2020.

Headquartered in Petaluma, the company has manufacturing operations in the U.S. and Latin America. European marketing and sales is headquartered in Roermond, Netherlands. In July it reported record quarterly prescriptions filled for the company’s dermatology products.

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