The FDA approved a generic roflumilast version manufactured by Zydus Pharmaceuticals USA Inc for the treatment of COPD, according to a company news release. Roflumilast has been marketed as DaliResp by AstraZeneca.

Roflumilast is an oral selective phosphodiesterase-4 (PDE4) inhibitor. Generic roflumilast is indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

The approval grants Zydus 180 days shared exclusivity for generic Roflumilast tablets 500 mcg. The company has also received tentative approval a 250 mcg dosage of the tablets.

generic roflumilast

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Go To Source For Respiratory Therapy Coverage

RT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry.Go To Source For Respiratory Therapy CoverageRT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry.