Breckenridge awarded US FDA approval for Roflumilast Tablets (Daliresp) ANDA
8 October 2018 -

Pharmaceutical marketing company Breckenridge Pharmaceutical Inc revealed on Friday the receipt of US Food and Drug Administration final approval for its Abbreviated New Drug Application for Roflumilast Tablets in 500mcg for the treatment of chronic obstructive pulmonary disease (COPD), a common lung disease.

The company added that the US FDA approval for Abbreviated New Drug Application for Roflumilast Tablets, 500mcg is the generic for Daliresp Tablets by AstraZeneca Pharmaceutical LP Breckenridge's Roflumilast Tablets product that was developed by Ferrer Internacional, S.A, headquartered in Barcelona.

According to the company, the 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.

For the year ended 31 August 2018, Daliresp generated annual sales of USD211m, according to industry sales data.

In conjunction, AstraZeneca, Breckenridge and Ferrer have signed 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.