The EMA has announced that its Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding a marketing authorization application submitted by Teva Pharma B.V. for a budesonide/formoterol DPI for the treatment of asthma and COPD. The budesonide/formoterol DPI will be available in 160 µg/4.5 μg and 320 μg/9 μg strengths.
The budesonide/formoterol DPI is a copy of Teva’s DuoResp Spiromax, which was approved in Europe via the centralized procedure in April 2014.
Read the EMA opinion summary.
