FDA sets record for num­ber of gener­ic drug ap­provals again

The FDA has ap­proved and ten­ta­tive­ly ap­proved more gener­ic drugs in FY 2018 than any oth­er year pri­or, the agency an­nounced Thurs­day.

The 971 to­tal in­cludes 781 fi­nal ap­provals and 190 ten­ta­tive ap­provals, which com­pares with 937 to­tal in FY 2017, which was the high­est num­ber of ap­provals since 2016, which at the time set the pre­vi­ous record.

“When I start­ed as FDA com­mis­sion­er, I made clear that one of my top pri­or­i­ties would be en­sur­ing the agency does all it can to help en­sure Amer­i­can pa­tients have ac­cess to af­ford­able, qual­i­ty med­i­cines that meet their needs. To ac­com­plish this, we have tak­en many im­por­tant ac­tions to en­cour­age the time­ly de­vel­op­ment and ap­proval of low­er-cost gener­ic drugs and are be­gin­ning to see re­sults,” FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment.

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