PETALUMA, Calif., Nov. 2 /PRNewswire/ -- Dow Pharmaceutical Sciences announced today that the US Food and Drug Administration (FDA) has approved Clobex® (clobetasol propionate) .05% Spray for the treatment of moderate-to-severe plaque psoriasis. Clobex® Spray, the only available super-high potency corticosteroid formulation that couples the clinically proven strength of clobetasol in an advanced, convenient, non-aerosol spray formulation, was developed by scientists at Dow Pharmaceutical Sciences. Dow also managed full product development, including nonclinical and clinical studies, and filed an electronic (eCTD) NDA for Clobex® Spray in December 2004. The product will be marketed by Galderma Laboratories, a leading worldwide dermatology company.
“We are really excited to have our second NDA approved this year,” said Dr. Bhaskar Chaudhuri, President and CEO of Dow Pharmaceutical Sciences. “Our unique spray formulation should be a welcomed treatment option for many psoriasis patients who struggle with this difficult to treat disease,” added Dr Chaudhuri.
“Galderma is pleased to be working with Dow Pharmaceutical Sciences,” said Albert Draaijer, President of Galderma Laboratories, L.P. “We are excited to launch Clobex® Spray as part of our Clobex® product line,” he added.
About Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences specializes in development of topical prescription drug products for pharmaceutical and biotechnology clients. They offer a full range of product development services including early stage formulation and regulatory consulting, formulation optimization utilizing state-of-the-art Skin Biology Laboratory tools, full analytical support and cGMP manufacturing and labeling of clinical trial materials. Dow conducts Phase 1-4 dermatology studies at clinical sites in Vallejo and Davis California, and provides full dermatology CRO services in Europe through its Bioskin Division headquartered in Hamburg, Germany.
Dow Pharmaceutical Sciences supports all aspects of regulatory and clinical planning and development, including FDA meeting support and regulatory document preparation and submissions. Clobex® Spray is Dow’s second electronic NDA approved in 2005 by the FDA’s Dermatology and Dental Division.
Source: Dow Pharmaceutical Sciences
