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Biotech / Medical : CollaGenex (CGPI) FDA PENDING
CGPI 0.00010000.0%Jul 21 5:00 PM EST

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To: Tom D who wrote (16)10/13/1997 4:31:00 PM
From: Jeffers Hughes   of 142
 
Check FDA agenda on Oct. 29 and 30 of Dental Plaque Advisory Committee. Unfortunately, CGPI's peridonstate is not included in the meeting. It seems that we have to wait for another long period because the next FDA meeting will be at least in next year.

DENTAL PLAQUE SUBCOMMITTEE OF THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE.

AGENDA:OPEN COMMITTEE DISCUSSION. On Wednesday, October 29, 1997, the Committee will
continue discussion and/or possibly vote on the safety and effectiveness of: C-31G, xylitol,
and zinc citrate, as well as the following combination ingredients: a) menthol, thymol,
eucalyptol, and methyl salicylate; b) hydrogen peroxide and povidone iodine; c) hydrogen
peroxide, sodium citrate, zinc chloride, and sodium lauryl sulfate. The subcommittee will
continue discussion of the criteria for OTC antiplaque and antigingivitis combination drug
products. On Thursday, October 30, 1997, the subcommittee will discuss the final formulation
testing for OTC antiplaque and antigingivitis drug products, and assignments will be made
for the review of foreign marketing data supporting OTC antiplaque and antigingivitis
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