FDA Novel Drug Approvals Reach 21-Year High
January 1, 2018 – The U.S. FDA approved a total of 46 novel drugs—which include New Molecular Entities (NMEs) and Biologic License Applications (BLAs)—through the Center for Drug Evaluation and Research (CDER) in 2017. This is the highest number approved in a single year since 1996, when the FDA approved 53 novel drugs. Nearly half (21) of 2017’s novel drugs are indicated to treat rare or orphan conditions.
These numbers do not account for all drug approvals granted by the FDA in 2017. A different arm of the administration, the Center for Biologic Evaluation and Research (CBER), approved eight additional drugs. These include five biosimilar drugs, as well as 2017’s groundbreaking CAR-T and gene therapies from Gilead, Novartis, and Spark Therapeutics. This brings the final total of drugs approved by the FDA in 2017 to 54, just shy of the record combined total of 56 drugs approved in 2015.
The FDA also approved two new vaccines in 2017: GlaxoSmithKline’s Shingrix, for the prevention of shingles, and Dynavax’s Heplisav-B, for the prevention of hepatitis B infection.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.