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Biotech / Medical : CollaGenex (CGPI) FDA PENDING -- Ignore unavailable to you. Want to Upgrade?

To: Tom D who wrote (22)	3/17/1998 10:39:00 AM
From: pat w.	Read Replies (2) \| Respond to of 142

CollaGenex Sees Periostat NDA Amendment In A Few Weeks NEWTOWN, Pa. (Dow Jones)--CollaGenex Pharmaceuticals Inc. (CGPI) plans to submit a new drug application amendment for Periostat to the Food and Drug Administration within the next few weeks. As reported Jan 28, the pharmaceutical company said the FDA cited additional issues related to its periodontal disease treatment in a second action letter and telephone conference. In a press release Monday, the company said it provided the FDA with information from a recent clinical trial that evaluated the efficacy of Periostat in combination with scaling and root planing. Scaling and root planing, or SRP, is a procedure in which bacterial deposits are mechanically removed from below the gum line. As reported Jan. 12, the company said patients that received Periostat as an adjunct to SRP showed statistically significant improvements, compared with placebo patients, in both probing pocket depths and clinical attachment levels. Collagenex agreed to seek a revised claim, and submit an NDA amendment containing the results from the recent trial. The FDA also agreed to review the amendment within six months of submission.