Thursday, January 19, 2017 10:00:13 AM
I may need new glasses, but at first glance it appears no ANDA has been approved since 2012. They are all sitting as "pending". I know much has been done over the past year or so to clean up the backlog, but this just goes to show the bureaucracy of the FDA. Can't keep their head above water.
When I think of FDA's ANDA backlog, I think of applications sitting around for 5 years without action. But looking at this graph, approx. 1/3 approved within ~3 years and a strong majority have had at least 1 review cycle with feedback from FDA (CRL). Without knowing the overall approval rate, it's hard to make much of the size of the blue bar (Approvals), and I'm more impressed with the shrinkage of the grey bar (Pending).
Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)
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