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FDA approves Forest Labs Daliresp

The US Food and Drug Administration (FDA) has approved Forest Laboratories' Daliresp (roflumilast) as a treatment for the reduction of the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

The company claims that Daliresp is a once-daily oral tablet and is the first and only selective PDE4 inhibitor approved by the FDA.
Daliresp will be available across the US in the second quarter of 2011.

Earlier, in August 2009 Forest Labs and Nycomed entered into a definitive collaboration and distribution agreement pursuant to which Forest acquired an exclusive license for Daliresp in the US.