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news.Horizon Pharma has modified the DUEXIS (ibuprofen/famotidine) marketing authorization application (MAA) submission to include the Valeant Pharmaceuticals manufacturing site in Quebec, Canada.
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The recently approved Valeant manufacturing site, previously owned and operated by Sanofi-Aventis, is used as the primary site to manufacture DUEXIS for the US market.
Horizon Pharma anticipates a decision on the updated MAA in the second half of 2012.
DUEXIS, indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, is approved and available in the US.