Here are four things to know.
1. The FDA broke a record by granting 927 generic drug approvals in 2017. This number includes both tentative and full approvals.
2. Tentative approvals are given to drugs that have been approved from a scientific perspective but for legal reasons — such as patents or exclusivities on the brand name drug — they cannot be fully approved, according to a blog post on the FDA’s website.
3. The agency approved 112 more generics in 2017 than in fiscal year 2016, which previously held the record, according to RAPS.
4. The trend of record-breaking years is attributed to FDA Commissioner Scott Gottlieb, MD, prioritizing the approval of generics to stem competition and bring down the cost of prescription drugs.
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