Breaking News, Collaborations & Alliances

Mylan, Theravance Biopharma Partner to Submit NDA

The drug is in development for the treatment of chronic obstructive pulmonary disease

Theravance Biopharma, Inc. and Mylan have partnered to submit a New Drug Application to the U.S. Food and Drug Administration for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist. The drug is a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease.   The application is supported by the companies’ Phase 3 program for revefenacin, which consisted of two replicate Phase 3 efficacy studies and a 12-mont...

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