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How many new drugs approved in 2023?

In 2023, CDER approved 55 novel drugs, as detailed in our annual New Drug Therapy Approvals report. The active ingredient(s) in a novel drug have not been previously FDA-approved. We also took other important actions, such as expanding the indications or patient populations of some previously approved therapies.

Why was pseudoephedrine taken off the market?

The Combat Methamphetamine Act of 2005 moved pseudoephedrine, which is quite effective for the temporary relief of nasal congestion, behind the counter of U.S. pharmacies. Pseudoephedrine was being used to produce illicit methamphetamines, and the U.S. Drug Enforcement Agency (DEA) wanted to limit its access.

What drug was taken off the market?

docHub withdrawals Drug nameWithdrawnRemarksFlupirtine2018Liver toxicity.Gatifloxacin2006Increased risk of dysglycemia.Gemtuzumab ozogamicin (Mylotarg)2010No improvement in clinical benefit; risk for death. Returned to market in 2017.Glafenine1984Anaphylaxis.114 more rows

What medications have been discontinued?

Discontinued Drugs Generic NameRevision DatePosaconazole Oral SuspensionJanuary 8, 2024Quinidine Gluconate InjectionMarch 4, 2020Ranitidine InjectionApril 2, 2020Reserpine Oral TabletsApril 15, 201633 more rows

How many new drugs does the FDA approve each year?

The 10-year graph below shows that from 2013 through 2022, CDER has averaged about 43 novel drug approvals per year. CDER identified 20 of the 37 novel drugs approved in 2022 (54%) as first-in-class. These drugs have mechanisms of action different from those of existing therapies.

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