INDIA BUSINESS WORLD - March 16th - March 31st - 2008
SUN PHARMA GETS FDA NOD TO MARKET GENERIC ETHYOL
Drug maker Sun Pharmaceutical Industries has said that it has received FDA approval for marketing a generic version of Medimmune's Ethyol amifostine injection, used in the treatment of cancer. Sun Pharma, being the first-to-file an ANDA for generic Ethyol has a 180-day marketing exclusivity, Sun Pharmaceutical said in a filing to the BSE adding that Ethyol has annual sales of around $80 million in the US. This generic amifostine injection is therapeutically equivalent to Medimmune's Ethyol amifostine injection of 500mg strength, the company added. Amifostine is used as an adjuvant in cancer treatment. Sun Pharma's amifostine injection would be used for reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.
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