Production of Catapres for Hypertension Discontinued
January 6, 2021Kala Pharmaceuticals Launches Dry Eye Treatment Eysuvis
January 7, 2021January 6, 2021 – The U.S. FDA approved 50 novel drugs in 2021, down from 53 in 2020. Over the last five years, the agency has approved an average of 51 novel drugs per year. Drugs are considered novel if the active ingredients have never before received U.S. FDA approval.
- The record for novel drug approvals by the agency in a single year is 59, set in 2018.
- More than half of the novel drug approvals in 2021 were for first-in-class therapies (54%) and/or the treatment of orphan or rare conditions (52%).
- The total for 2021 does not include vaccines, such as Pfizer's Comirnaty® (COVID-19 vaccine, mRNA), allogenic products such as Enzyvant Therapeutics' Rethymic® (allogeneic processed thymus tissue-agdc), or CAR-T therapies such as Celgene's Abecma® (idecabtagene vicleucel). The FDA counts such products separately.