Women's Health Weekly
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Drug Development
Pharmaceutical company seeks global regulatory approval of antibiotic
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...
Source: Women's Health Weekly (2005-01-13)
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