Daliresp FDA Approval History
FDA Approved: Yes (First approved February 28, 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 timeline for Daliresp
Date | Article |
---|---|
Mar 1, 2011 | Approval FDA Approves Daliresp to Treat Chronic Obstructive Pulmonary Disease |
Sep 13, 2010 | Forest Responds to FDA Complete Response Letter for Roflumilast |
May 18, 2010 | Nycomed And Forest Laboratories Receive Complete FDA Response Letter For Roflumilast |
Jul 23, 2009 | Nycomed Announces FDA Filing for Daxas in COPD |
Further information
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