Drug Development

Pharma company to present MT 100 to FDA advisory committee

Published in Medical Letter on the CDC and FDA, January 23rd, 2005

The U.S. Food and Drug Administration (FDA) and POZEN Inc. (NASDAQ: POZN) have agreed to present MT 100 to an advisory committee for consideration, with particular emphasis on the potential risk of tardive dyskinesia.

This action came as a result of a series of meetings held between the two parties. The FDA stated in a recent memo that it is possible that MT 100 may not be approvable if the benefits of the drug do not, in FDA's opinion, outweigh the risks of MT 100, including the risk of tardive dyskinesia, even if FDA eventually determines that MT 100 meets the efficacy requirements for a combination migraine agent.

MT 100 is a combination of two...

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Source: Medical Letter on the CDC and FDA (2005-01-23)

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