New Drugs Approved in 2021.

Ebied, Alex M; Elmariah, Hesham; Cooper-DeHoff, Rhonda M

Ebied, Alex M; Elmariah, Hesham; Cooper-DeHoff, Rhonda M.

Ebied AM; Department of Clinical Sciences, Fred Wilson School of Pharmacy, High Point University, High Point, NC. Electronic address: ebiedrx55@gmail.com.
Elmariah H; Department of Internal Medicine, Mount Sinai Beth Israel Hospital, New York, NY.
Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville.

Am J Med ; 135(7): 836-839, 2022 07.

Article in English | MEDLINE | ID: covidwho-1698110

ABSTRACT

ABSTRACT

In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved through an expedited review pathway, and 26 of the 50 (52%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2021.

Subject(s)

Drug Approval; Humans; Pharmaceutical Preparations; United States; United States Food and Drug Administration

Keywords

Accelerated approval; FDA; Fast track; Novel drugs; Priority review

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug Approval Limits: Humans Country/Region as subject: North America Language: English Journal: Am J Med Year: 2022 Document Type: Article

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