The FDA approved 46 novel drugs in 2017. This made news, since it was the highest number of drugs approved in a year since 1996. The FDA surpassed the 2017 total in October 2018, with 47 drugs being approved since the beginning of the year. In November 2018, eight more drugs were approved, raising the 2018 total to 55. This surpassed the all-time high of 53 novel drug approvals established in 1996.
Over three-quarters of the drugs had priority review status. All 55 drugs met their PDUFA goal date and 39 were approved in the US before other countries. If the FDA stays with the average of 5 approvals per month, it will reach 60 by the end of the year.
Leading the way in approvals this year have been 32 orphan drugs, those budget buster specialty pharmacy products that play havoc with our drug spend. 2018 is the first year that more than half of the approved new drugs had orphan indications. It is interesting to note that the number of orphan drugs approved is more than the total number of drugs approved in three of the past seven years.
The Prescribe Right Pharmaceutical Pipeline Tracker is tracking three drugs with PDUFA dates at the end of December:
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