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Roflumilast Approval
[Oct 05, 2018]

FOR IMMEDIATE RELEASE                                               


October 5, 20187006 Contact us at


Breckenridge Announces Final Approval of its ANDA for Roflumilast Tablets (Daliresp®)


Boca Raton, Florida, October 5 2018– Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Roflumilast Tablets, 500mcg, generic for Daliresp® Tablets by AstraZeneca Pharmaceutical LP.  Breckenridge’s Roflumilast Tablets product was developed by Ferrer Internacional, S.A.


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.


About Breckenridge:

Breckenridge Pharmaceutical, Inc. is a privately-held own-label distributor that performs pharmaceutical marketing, research and development, as well as marketing and distribution in the U.S. The company was founded in 1983 and markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including:tablets, capsules, liquids, suspensions, ophthalmics, nasal sprays, powders and injectable products.


About Ferrer

Founded in 1959, Ferrer is a privately-held international chemical-pharmaceutical company headquartered in Barcelona. It is active throughout the full value chain, from R&D to international marketing. It is present in more than 110 countries, with 19 international affiliates. It is active in the pharmaceutical, health, fine chemical and food sectors, key areas for contributing to people’s health and wellbeing.


Since the beginning, Ferrer has been committed to the research and development of innovative medicinal products and to maintain a solid industrial structure. Ferrer’s activity across the entire healthcare spectrum includes prescription drugs, hospital products, diagnostics, vaccines, as well as fine chemicals, food and feed.

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