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New Molecular Entity (NME) Systemic Antibiotics Approved by the FDA 1980-2009, but Subsequently Withdrawn or Discontinued

New Molecular Entity (NME) Systemic Antibiotics Approved by the FDA 1980-2009, but Subsequently Withdrawn or Discontinued

Arguing that a simple count of new antibiotic approvals may not be adequate for a complete picture of antibiotic development, Outterson et al. analyze data on the approval and withdrawal of new antibiotics and other antiinfectives in the US during 1980-2009. Their study titled, “Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009,” is published in the Journal of Law, Medicine & Ethics.

The study finds that 26 of the 61 NME approved antibiotics were withdrawn during the study period. Using data from the study, our graphic shows the dates for approval, discontinuation and withdrawal for each of the 26 antibiotics.

This study finds that nineteen antibiotics were not commercially or clinically successful and were ultimately withdrawn or discontinued from the market. Six antibiotics were formally withdrawn for safety-related reasons, while for others, safety questions played a role in limiting clinical and commercial success. Additionally, the study did not find the emergence of antibiotic resistance to be a reason for any of the withdrawals. During this period, antibiotics suffered market withdrawals at triple the rate of all other FDA-approved drugs.

The study suggests that the clinical quality of new antibiotics should be a focus, in addition to the number of new antibiotic introductions.

For more information:

  • Professor Outterson’s blogpost on this topic.
  • Published study in the Journal of Law, Medicine & Ethics.