Dow Pharmaceutical Sciences Receives FDA Approval of NDA for Galderma's Clobex(R) Spray for Moderate-to-Severe Plaque Psoriasis

Nov 02, 2005, 00:00 ET from Dow Pharmaceutical Sciences

    PETALUMA, Calif., Nov. 2 /PRNewswire/ -- Dow Pharmaceutical Sciences
 announced today that the US Food and Drug Administration (FDA) has approved
 Clobex(R) (clobetasol propionate) .05% Spray for the treatment of
 moderate-to-severe plaque psoriasis. Clobex(R) 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(R) Spray in December
 2004. The product will be marketed by Galderma Laboratories, a leading
 worldwide dermatology company.
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     "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(R) Spray as part of our Clobex(R) 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(R) Spray is Dow's
 second electronic NDA approved in 2005 by the FDA's Dermatology and Dental

SOURCE Dow Pharmaceutical Sciences