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Dow Pharmaceutical Sciences Announces FDA
Approval of METROGEL® (metronidazole) Topical Gel 1% for Rosacea
Petaluma, CA; July 6, 2005 — Dow
Pharmaceutical Sciences announced today that the US Food and Drug Administration
(FDA) has approved MetroGel® (metronidazole) Topical Gel 1% for the topical
treatment of inflammatory lesions of rosacea. This unique product was
formulated, patented and developed by Dow Pharmaceutical Sciences and will be
marketed in the United States through an alliance with Galderma Laboratories, a
leading worldwide dermatology company.
"We are happy to be associated with a strong marketing partner like Galderma”
said Dr. Bhaskar Chaudhuri, President and CEO of Dow Pharmaceutical Sciences.
“Galderma’s current metronidazole product line is the leading therapy for
rosacea patients in the United States, and the addition of our unique
formulation and strength should further enhance the success of this product
line” added Dr Chaudhuri. “Galderma is one of the major companies in
dermatology, and we are fortunate to have them as our marketing partner.”
“We are pleased to be working with Dow Pharmaceutical Sciences,” said Albert
Draaijer, President of Galderma Laboratories, L.P. “This is an exciting new
addition to our topical metronidazole product line” he added.
About Dow Pharmaceutical Sciences
Dow Pharmaceutical Sciences, with laboratories in Petaluma, California,
specializes in development of topical drug products for pharmaceutical and
biotechnology clients. The company provides a full range of product development
services including early stage formulation, regulatory and clinical consulting,
formulation optimization utilizing their state-of-the-art Skin Biology and Drug
Delivery Laboratory, analytical methods development and stability testing, and
cGMP manufacturing and labeling of clinical trial materials for phase 1-2
trials.
Dow Pharmaceutical Sciences supports all aspects of regulatory and clinical
planning and development, including non-clinical and clinical study design and
management, FDA meetings, and preparation of all regulatory filings required to
take dermatology products through FDA approval. Dow has dermatology clinical
sites in Vallejo and Davis California, and full dermatology CRO capabilities in
Europe through its Bioskin Division located in Hamburg and Berlin Germany.
Contacts:
Steven R. Smith
Vice President, Business Development
Dow Pharmaceutical Sciences
Petaluma, California
707-665-4672
ssmith@dowpharmsci.com
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