Drug Development

Pharmaceutical company seeks global regulatory approval of antibiotic

Published in Women's Health Weekly, January 13th, 2005

Wyeth Pharmaceuticals, a division of Wyeth (WYE), announced that the company has submitted a global registration dossier for its investigational antibiotic Tygacil (tigecycline).

This is the first time Wyeth has applied simultaneously for global approval of a new product. This registration package included the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA), as well as a marketing authorization application (MAA) with the European Medicines Agency and additional filings with authorities in Canada, Australia, and Switzerland.

Wyeth is seeking market approval for Tygacil as a single agent therapy to treat...

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Source: Women's Health Weekly (2005-01-13)

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