Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product
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.
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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.’
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.
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.