An­oth­er record year for gener­ic drug ap­provals but ques­tions on com­pe­ti­tion re­main

For each of the last five years, the FDA has set gener­ic drug ap­proval records, but ques­tions have lin­gered on whether these high ap­proval num­bers are trans­lat­ing in­to com­pe­ti­tion.

FY 2019 fig­ures show a to­tal of 1,171 gener­ic drug ap­provals (935 full ap­provals and 236 ten­ta­tive ap­provals), which breaks the FDA’s pre­vi­ous all-time record of 971 full and ten­ta­tive ap­provals for FY 2018. And al­though the ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA) ap­proval record was tech­ni­cal­ly bro­ken in Au­gust of this year, the FDA is ap­prov­ing in­creas­ing num­bers of com­plex gener­ics, which can be more dif­fi­cult to copy and tra­di­tion­al­ly lack com­pe­ti­tion.

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