Breckenridge Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application for Roflumilast Tablets, 500mcg, generic for Daliresp Tablets by AstraZeneca Pharmaceutical. Breckenridge's Roflumilast Tablets product was developed by Ferrer International.
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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 generated annual sales of $211,000,000 during the year ended August 31, 2018, according to industry sales data.
AstraZeneca, Breckenridge, and Ferrer have entered into a confidential settlement agreement regarding the Hatch-Waxman litigation for Roflumilast. Breckenridge, as authorized by the settlement agreement, may sell or offer to sell Roflumilast at a later date. Further announcements will be made prior to product launch.