Last year was a huge year for novel drug approvals—a 21-year high with 46 approvals—so don’t expect this year to match it. But at the time of writing last year, the FDA had only approved six new drugs, compared to five this year, so it isn’t that much of a drop-off so far.
March 2017, however, was a huge month, seeing seven new approvals within just 15 days, so it remains to be seen if 2018 will be able to keep pace. Generic drug approvals are already falling behind—despite the FDA’s goal to keep its furious pace going—with a dismal 25 approvals in January and 32 in February, compared with 84 and 78 in the final two months of 2017, respectively. According to Regulatory Focus, this slowdown is due to a new rule implemented January 1st designed to limit elemental impurities. Regardless of new rules, however, 2018 is still pacing well ahead of 2016’s abysmal 22 approvals.
Here are the first five novel drug approvals of the year, including two new HIV medications.