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Executive Summary

The new 200 mg dose of ibuprofen required an NDA for approval for OTC marketing because "it has not been used to a material extent and for a material time," FDA declared in a May 18 response to the Chattem citizen petition to halt the NDA proceedings on the ingredient. "Experience with ibuprofen marketed as 300 mg, 400 mg and 600 mg strengths is pertinent to an evaluation of the drug's safety," FDA Associate Com. Joseph Hile told Chattem, "but such experience cannot support general recognition that the product, at a different strength and daily dose, can be used safely and effectively by the patient alone." The FDA response to Chattem's petition -- issued on the same day as agency approval of the ibuprofen OTC NDA -- sets at least one firm policy for Rx-to-OTC switches: a new dosage form of a switched product requires an NDA application and cannot be handled under the OTC Review monograph procedures. "Even if it could be established . . . that the 200 mg strength of ibuprofen had become generally recognized as safe and effective as a result of the investigations reported in the medical literature," Hile wrote, "the FDA has concluded that the drug should be regarded as a new drug within the meaning of 21 USC 321(p)(2), because it has not been used to a material extent and for a material time. A drug that has not been used to a material extent or for a material time is not appropriately included in the OTC monograph system." Technically, the ibuprofen approval is not viewed by FDA as an Rx-to-OTC switch. The agency observed that the 200 mg dose was not a previously marketed product. "Your petition," FDA told Chattem, "does not support your premise that the proposed approval of ibuprofen for OTC use involves a switch from Rx to OTC status. As noted . . . a 200 mg strength of ibuprofen has never been marketed in the U.S." Answering the Chattem request that the agency promulgate a policy for switching ingredients, FDA maintained that both the NDA procedures for moving an Rx product to OTC and the OTC Review procedures provide for public notice and comment on a switch. "FDA's established policy on switching Rx drugs to OTC status provides opportunity for public notice and comment, even where such switches are initiated through the filing of a supplemental NDA."

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