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FDA grants Fast Track designation for investigational oral mucositis drug.
2003 MAR 6 - (NewsRx.com & NewsRx.net) -- 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 designation.
Dr. Edward Shinal, Aesgen, Inc., stated, "Currently, there are no approved treatments for chemotherapy-induced mucositis and we believe that AES-14 has the potential to significantly reduce the incidence and severity of this serious medical condition. AES-14 represents a new approach in oral mucositis treatment and we are very excited about receiving Fast Track designation from the FDA."
AES-14 is a proprietary mouth rinse suspension that is used two or three times per day during chemotherapy. AES-14 has been ...
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Source: HighBeam Research, FDA grants Fast Track designation for investigational oral mucositis...