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Wisconsin Pharmacal

This article was originally published in The Gray Sheet

Executive Summary

FDA approves premarket approval application supplement for production of the company's Reality female condoms at Chartex International's London, England plant. The company's original PMA, approved in May 1993, covered a limited-capacity facility in Jackson, Wisconsin ("The Gray Sheet" May 17, 1993, p. 6). With FDA approval of the large-capacity Chartex facility, Wisconsin Pharmacal will begin sales to approximately 5,000 public health clinics within 30 days. Retail marketing will start in July "with national distribution completed by fall," the firm says. The company has been selling the devices to a limited number of public health clinics since September 1993, and has "a current back order of four to six months"
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