22 Novel Drugs Approved by FDA in 2016

Every year, the FDA’s Center for Drug Evaluation and Research (CDER) approves new medications. Some medications are variations of existing products, such as generic formulations or new dosage forms of previously-approved products. Other medications are novel drugs, having chemical structures that have never previously been approved for human use.  

Novel Drug List

The CDER publishes a summary of the approved novel drugs on the FDA website. The FDA recently released the summary of the novel drugs approved in 2016 (click here for the full summary). The summary includes 22 novel drugs, approved either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).  The table below lists the 22 novel drugs approved in 2016 and related approval information.

Lower Than Average Approval Number

The number of approved novel drugs in 2016 is less than half of the 45 novel drugs approved in 2015. The chart below illustrates the novel drug filings and approvals in each year of the past decade. The vertical bars in the graph indicate the number of novel drugs approved, and the points connected by lines indicate the number of new applications filed. From 2007 through 2015, CDER received an average of about 36 applications for novel drugs per year, while the average approval number remained about 29 drugs per year. While the approval numbers were down, CDER estimated 41 filings for 2016, higher than the average in recent years.

John Jenkins, director of FDA’s Office of New Drugs, who retired from the FDA on January 7, 2017, provided several explanations for the lower number of novel drugs approved in 2016 on the FDA’s blog. One reason he offered was that CDER approved five novel drugs in 2015 that had originally been planned for approval in 2016. Another reason he mentioned was a higher number of Complete Responses (CR) in 2016.  Issuance of a CR provides advice on what the sponsor needs to do for FDA to support resubmission of the application. CDER issued 14 CR letters for novel drugs in 2016, higher than in recent years.

Approval Number Break Down

Despite the lower number of approvals, The FDA’s Novel Drug Summary for 2016 notes that the approved drugs have the potential to have a big impact in several therapeutic areas. Eight of the drugs approved last year were identified as “first in class” treatments, and nine (41%) of the novel drugs were approved as orphan drugs. An orphan drug is one that treats rare diseases that affect fewer than 200,000 Americans. A majority of the novel drugs approved in 2016 benefited from the FDA’s programs to expedite its review process:  eight of the twenty-two drugs had a fast track status for drugs having the potential to address unmet needs; seven were considered breakthrough therapies with preliminary clinical evidence demonstrating substantial improvement over other available therapies; fifteen received a priority review designation for review within six months instead of the standard 10 months; and six benefited from the accelerated approval for early approval for a serious or life-threatening illness with benefit over existing therapies. The FDA’s report also noted that 19 of the 22 novel drugs were approved in the United States before receiving approval in any other country.