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Sonoma Pharma gets US FDA approval to add antimicrobial language to alevicyn gel products for management of atopic dermatitis

Petaluma, California
Thursday, December 7, 2017, 16:00 Hrs  [IST]

Sonoma Pharmaceuticals, a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care,  announced that the US Food and Drug Administration (FDA) has approved an expanded antimicrobial claim for the company's key dermatology gel product, Alevicyn SG Antipruritic Spray Gel, reflecting the product's widening clinical utility.

"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. "Our family of Alevicyn dermatology products can be prescribed with the confidence they are simultaneously safe, antimicrobial and efficacious in the management of various inflammatory skin dermatoses including atopic dermatitis and eczema."

The first regulatory clearance to expand label language with antimicrobial claims was issued in November by the FDA for the Alevicyn Dermal Spray.

Alevicyn products, available via prescription, provide dermatologists with a safe and clinically proven approach to management of many inflammatory skin diseases, including atopic dermatitis—without the side effects of topical steroids and resistance issues associated with the overuse of antibiotics. In addition, the Alevicyn family of products are being used in both pre- and post-procedures, including skin cancer procedures.  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.  For more information visit www.alevicyn.com.


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