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FDA Approval Activities for this Drug…
ETHYOL (amifostine) Injection, MedImmune Oncology, NDA 20-221/S-017 3/27/03 4/15/03 4/1/03 ETHYOL (amifostine) Injection, MedImmune Oncology, NDA 20-221/S-015 2/20/02 2/21/02 ETHYOL (amifostine) Injection, 500mg (amifostine anhydrous base), US Bioscience NDA 20-221/S-012 6/24/99 6/25/99 6/25/99 6/22/01 Ethyol Indication: To reduce the incidence of moderate to severe xerostomia in patients undergoing post-ooperative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands (see Clinical Studies). | Ethyol (amifostine) Injection, MedImmune Oncology, Labeling Revision | Amifostine Injection, Sun Pharma, Tentative Approval
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