Mylan’s Generic Advair Approval Showcases US FDA Efforts To Boost Complex Products
Executive Summary
Commissioner Gottlieb previews actions agency intends to take in 2019 to smooth the regulatory and scientific pathway for generics of complex drugs, including draft guidance with recommendations on establishing active ingredient sameness.
You may also be interested in...
FDA Eyes Adverse Events For Mylan's Wixela Inhub
As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.
Adverse Events For Generic Of GSK's Advair Diskus On US FDA’s Radar
As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.
For Novartis' Generic Advair, Another 18 Months Was Too Far Into The Unknown
Company did not kill its development program because of US FDA feedback, but the experience seems to be another lesson in the difficulty in gaining approval for complex generics.