Collagen Corp. (NASDAQ:CGEN) announced Monday that it hasreceived an "Approvable Letter" from the FDA on its ContigenBard collagen implant.
The FDA apparently indicated that it was ready to approve thePalo Alto, Calif., firm's product for marketing H subject tocertain requests. According to company spokesman Bruce Voss,the letter contains 11 questions relating to labeling, clinicaldata, a post-approval study and marketing materials.
This latest letter from FDA comes after Collagen "submittedadditional data analyses [on Contigen] in December 1992," saidHoward Palefsky, Collagen's president and chief executiveofficer. Those analyses were for "additional subsetting of thedata that had been submitted in August," Voss said.
Contigen implant is an injectable collagen product designed toincrease urethral tissue bulk and resistance to the involuntaryloss of urine. Collagen is developing the product with theurological division of C.R. Bard Inc. of Murray Hill, N.J., whichhas exclusive marketing rights to the product.
-- Jennifer Van Brunt Senior Editor
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