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Executive Summary

IBUPROFEN/CODEINE ANDA SUITABILITY BASED ON IBUPROFEN SIMILARITY TO ASPIRIN was requested in a recent petition by McNeil to FDA. "If aspirin and acetaminophen are interchangeable in combination with codeine, then certainly ibuprofen 200 mg should be approvable as a substitute for acetaminophen in the acetaminophen and codeine combinations," McNeil contended. "Because the safety and efficacy of aspirin in combination with codeine is well-established, no preclinical or clinical data are necessary to support the safety and efficacy of 200 mg ibuprofen in combination with codeine." The company referred to a number of studies in the Upjohn and American Home Product OTC ibuprofen NDAs to support its position that the ingredient is comparable in safety and efficacy to aspirin and acetaminophen. Further, McNeil said, the aspirin and ibuprofen mechanisms of action are "similar." McNeil maintained that the ibuprofen/codeine combination meets the requirements for ANDA suitability outlined in the new ANDA/patent law for drugs not containing ingredients identical to those in already-approved products. Under the law, McNeil pointed out, a combination with one ingredient different from an already approved product may be approved with an ANDA, provided the new ingredient is approved and "of the same pharmacological or therapeutic class as the substituted ingredient in the" original product, or "listed drug." The law provides 90 days for FDA to answer the petition. According to the law, FDA must approve the petition unless the agency determines safety and efficacy studies must be conducted or that any drug with a different active ingredient from the listed drug may not be approved under ANDA procedures. The company also maintained that an ibuprofen/codeine combination is "closely related" to DESI effective compounds. McNeil noted that ANDAed combinations of peripheral analgesics with codeine refer to a 1973 NDA for Trigesic, an aspirin, acetaminophen, caffeine, codeine product.

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