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Duexis FDA Approval History

FDA Approved: Yes (First approved April 23, 2011)
Brand name: Duexis
Generic name: famotidine and ibuprofen
Dosage form: Tablets
Company: Horizon Pharma, Inc.
Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis

Duexis (ibuprofen and famotidine) is an NSAID and histamine H2-receptor antagonist combination indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper GI ulcers.

Development timeline for Duexis

Apr 25, 2011Approval Horizon Pharma Announces FDA Approval of Duexis (Ibuprofen/Famotidine)
May 26, 2010Horizon Pharma, Inc. Announces FDA Acceptance of Duexa New Drug Application for Filing

Further information

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