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H. pylori ulcer treatment NDAs understood to be set for Dec. 13 FDA advisory committee review.

Executive Summary

H. PYLORI DRUG THERAPY NDAs: FDA ADVISORY COMMITTEE REVIEW appears set for mid-December. FDA has applications pending for treatment regimens for Helicobacter pylori-induced gastric ulcers from at least three sponsors. The agency previewed some of the issues pertaining to H. pylori reviews at a joint meeting of the Gastrointestinal and Anti-Infective Drugs Advisory Committees on Oct. 26 ("The Pink Sheet" Nov. 6, p. 10). Reflecting the interest in the new ulcer regimens, FDA is apparently moving quickly back to the advisory committee for review of specific applications. FDA's Anti-Infective Drugs Advisory Committee has a meeting date scheduled for Dec. 13.

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