Breckenridge gets FDA approval for generic Daliresp for COPD

BY Sandra Levy

Breckenridge Pharmaceutical has received the FDA nod for roflumilast tablets, 500 mcg.

The product is the generic of AstraZeneca’s Daliresp tablets.

Roflumilast tablets are a selective phosphodiesterase 4 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.

Daliresp had a market value of $211 million for the year ended Aug. 31, 2018, according to industry sales data.

Roflumilast tablets were developed by Ferrer Internacional, S.A.


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