The FDA has approved Stiolto Respimat, tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. Click to read more
Novartis has announced positive results from several Phase 3 studies of NVA237 glycopyrronium bromide and QVA149 indacaterol/glycopyrronium bromide, both delivered by the Breezhaler DPI for the treatment of COPD. NVA237 is marketed as Seebri Breezhaler outside of the US, and QVA149 is marketed as Ultibro Breezhaler outside of the US. Click to read more
The FDA has approved GSK’s supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Click to read more.
The FDA has released a new draft guidance with recommendations for testing bioequivalence of MDI products containing the active ingredient ipratropium bromide. Check out our Regulatory Guidance page for this and other regulatory information.
Developing an In Vitro Understanding of Patient Experience with Hydrofluoroalkane-Metered Dose Inhalers
Posted 25 March 2013 By Alexander Gaffney, RF News Editor Say goodbye to China’s State Food and Drug Administration (SFDA); instead, say hello to its new name, the China Food and Drug Administration (CFDA). [Read more…]