FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

In This Issue

The FDA approved 48 novel drugs and biologics in 2017. About 20% of the new approvals were the first of a new drug class (eg, cerliponase alfa, emicizumab, enasidenib, letermovir, midostaurin, netarsudil ophthalmic, tisagenlecleucel, voretigene neparvovec).

The content in this issue of FDA New Drug and Biologic Approvals – 2017 Year-in-Review describes new molecular entities, new biologics, and select new indications approved by medical specialty during 2017.

Each drug or biologic summary contains information on the indication, mechanism, dosage, and FDA basis for approval.

You can scroll through all the drugs and biologics sequentially, or you can choose specific ones listed individually in the scroll bar.

For more information, each drug and biologic is linked to its corresponding Medscape monograph.

Reference:

U.S. Food and Drug Administration. Novel Drug Approvals for 2017. Accessed December 27, 2017. https://www.fda.gov/Drugs/Development
ApprovalProcess/DrugInnovation/ucm537040.htm

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