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Daliresp Approval History

  • FDA approved: Yes (First approved February 28th, 2011)
  • Brand name: Daliresp
  • Generic name: roflumilast
  • Dosage form: Tablets
  • Previous name: Daxas
  • Company: Allergan plc
  • Treatment for: COPD

Daliresp (roflumilast) is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Development History and FDA Approval Process for Daliresp

Mar  1, 2011Approval FDA Approves Daliresp to Treat Chronic Obstructive Pulmonary Disease
Sep 13, 2010Forest Responds to FDA Complete Response Letter for Roflumilast
May 18, 2010Nycomed And Forest Laboratories Receive Complete FDA Response Letter For Roflumilast
Jul 23, 2009Nycomed Announces FDA Filing for Daxas in COPD

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