The FDA's pattern of approving high numbers of generic drug applications to increase market competition has slowed in recent months. The latest release of raw data on Tuesday showed an all time high amount of complete response letters, or rejections, for abbreviated new drug applications in the month ending April 16.
Here are five main takeaways from the report:
- The FDA rejected 190 ANDAs, approved 53 and tentatively approved 16 in the month ending April 16.
- Those 190 rejections represent a 30 percent increase from the second highest month, which saw 147 rejections for the month ending March 16.
- For the 2016 fiscal year, the FDA has already rejected 879 ANDAs, more than 21 percent of which occurred in late March and April.
- The FDA has already approved 397 ANDAs in this fiscal year, putting it on pace to nearly double the 492 ANDAs approved in 2015.
- This significant increase in ANDA approvals and rejections in 2016 stems from the nearly 1,000 new FDA employees the agency hired to address the growing ANDA backlog.
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