Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product
Executive Summary
Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.
You may also be interested in...
Mylan To Explore Strategic Options, Claiming Investors Have Failed To Appreciate The Value
CEO Heather Bresch gave a soliloquy on US health care during the second quarter call, saying ‘perverse incentives’ have created a system that ‘feeds on higher prices.’
Express Scripts Rewards Low List-Priced Brands In 2019 Formulary, Retains Focus On Rebates
Mylan’s Symfi and Merck’s Zepatier gain preferred status on PBM's national preferred formulary for 2019. But more drugs are excluded from coverage – 242, up from 196 in 2018.
Mylan Communications With CMS To Get Outside Review Under EpiPen Settlement
Corporate integrity agreement requires Mylan to have an independent body review its drug classifications and US best price determinations; settlement resolves claims Mylan misclassified EpiPen to underpay rebates. Sanofi acted as whistleblower in case.