FDA in 2016 by the figures

What follows are the figures related to FDA activity in 2016. The US Agency approved 22 new drugs — down from 45 in 2015. However, some approvals were relevant, including those of MSD’ s Zepatier, Genentech’s Tecentriq and Sarepta’s much-debated Exondys 51 — the first treatment for Duchenne muscular dystrophy. The FDA’s Office of Prescription Drug Promotion issued 11 letters. Three of these were warning letters, which are typically reserved for serious infractions. Nine drugs with a Breakthrough Therapy designation were approved, including Gilead’s Epclusa and Genentech’ s Venclexta. Finally, FDA issued two Priority Review vouchers in 2016 for PaxVax’s Vaxchora and Sarepta’s Exondys 51. (Source MM&M)