www.fdanews.com/articles/84885-collagenex-pharmaceuticals-announces-filing-of-marketing-authorization-application-for-oracea
COLLAGENEX PHARMACEUTICALS' ANNOUNCES FILING OF MARKETING AUTHORIZATION APPLICATION FOR ORACEA
February 27, 2006
CollaGenex Pharmaceuticals, Inc. announced today that a Marketing Authorization
Application (MAA) for Oracea, has been filed with the United Kingdom's Medicines
& Healthcare Products Regulatory Agency (MHRA). The UK will act as reference
member state in this decentralized procedure. The MAA for Oracea was submitted
to the MHRA on February 24, 2006. A New Drug Application for Oracea was filed
with the U.S. Food and Drug Administration in August 2005 and has been given
a PDUFA date of May 31, 2006.
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