Contigen Bard is approvable
This article was originally published in The Gray Sheet
Executive SummaryBard and Collagen Corp. receive FDA approvable letter March 19 for the jointly developed bovine collagen urinary stress incontinence product. Bard says the letter requests "routine" information on labeling, clinical data and postmarket surveillance studies. If approved by the agency, Contigen Bard would be the first injectable urinary stress incontinence product on the U.S. market. Under a 1987 agreement, Collagen will manufacture the product and supply it in bulk to Bard, which will package and distribute it under a worldwide, exclusive marketing license. Upon FDA approval, Bard "will conduct FDA-required physician training and then begin a full commercial launch," the company says in a March 22 release. The premarket approval application for Contigen Bard was initially submitted in March 1989 and received an approvable recommendation from FDA's gastroenterology-urology devices panel in October 1990; the PMA was subsequently amended to respond to FDA data requests in 1991 and the fall of 1992 ("The Gray Sheet" Oct. 26, p. 15).
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