FDA Premarket Approval:

Process of Approving Lodine as a Drug

HRD-93-81: Published: Apr 12, 1993. Publicly Released: May 12, 1993.

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Pursuant to a congressional request, GAO reviewed the approval of the nonsteroidal, anti-inflammatory drug (NSAID) Lodine.

GAO found that: (1) the drug manufacturer requested an extension of its patent because the Food and Drug Administration (FDA) took 97 months to approve the drug, which was significantly longer than the average review period for NSAID; (2) the FDA approval period for the drug increased because FDA began closer scrutiny of new NSAID applications due to reported adverse reactions to similar drugs, assigned the drug its lowest review priority, and gave a higher priority to reviewing new generic drugs; (3) the drug's application was disorganized and difficult to review and its clinical tests were flawed; (4) Canada raised concerns about the drug's potential carcinogenicity in animals in 1984; and (5) FDA took 2 years to resolve the carcinogen issue before assigning a new medical examiner to the drug, who then reviewed all the previous submissions for the drug before completing his review.

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