ANDA Applications Track Toward New Records in Fiscal 2017

On April 7, 2017 FDAnews Drug Daily Bulletin reported that “Fiscal 2017 could be a record-setting year for ANDA applications if trends continue. Following a wave of ANDAs in December 2016, the number of applications received by the FDA is up by 50 percent over the same point in fiscal 2016 — already matching the total for all of fiscal 2015.”  By April 17, it was reported that “March Sees New Surge of Nearly 200 Submitted ANDAs”. The FDA received a fresh wave of ANDAs in March, nearly doubling the total amount from the first two months of the year.

Here’s a link to FDA’s most recent FY 2017 Report of the Generic Drug Program to see the numbers for yourself.  If you are considering development of a complex generic, click here to contact us.