Cancer Chemotherapy

FDA grants Fast Track designation for investigational oral mucositis drug

Published in Cancer Weekly, March 4th, 2003

Aesgen, Inc., a privately held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the company's investigational new drug, Aesgen-14 (AES-14), for oral mucositis associated with cancer chemotherapy.

Fast Track designation is intended to expedite the regulatory review and approval process for a product and claim that addresses a significant unmet medical need. The company is in Phase III clinical trials in the U.S. and overseas with AES-14 treatment during chemotherapy for breast cancer. Aesgen plans to submit a New Drug Application (NDA) to the FDA in 2003 under this Fast Track...

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Source: Cancer Weekly (2003-03-04)

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