16.09.2014 13:40:51

Mylan To Commence Phase III Trial For Its Generic Version Of Advair Diskus

(RTTNews) - Mylan Inc. (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus. Two Phase III clinical trials for Mylan's insulin analog program already are underway. In August 2014, the company initiated INSTRIDE 1 and INSTRIDE 2 to compare the efficacy and safety of Mylan's insulin Glargine with that of Lantus in both Type 1 and Type 2 diabetes mellitus patients.

In October 2014, Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients. The clinical trial is a randomized, double-blind, double dummy, parallel group study to determine the local equivalence of multiple doses of Mylan's generic product to Advair Diskus when administered via oral inhalation in adult asthma patients. The study is expected to be completed in April 2015.

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