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In Brief: Private-label Midol

This article was originally published in The Tan Sheet

Executive Summary

Private-label Midol: ANDAs for ibuprofen 200 mg capsules may be approved by FDA because the drug "was not withdrawn from sale for reasons of safety or effectiveness," the agency announced in a recent Federal Register notice. Responding to a June 27 citizen petition from Pharmaceutical Formulations of Edison, N.J. (formerly Private Formulations) regarding the status of the ibuprofen formulation, FDA determined that "never marketing an approved drug product is equivalent to withdrawing the drug from sale." Sterling Winthrop received approval for Midol 200 mg capsules on Sept. 7, 1987, but neither Sterling nor Bayer, which acquired Sterling's North American OTC business in late 1994, has marketed the product in that dosage strength...

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