Caraco's launches Sun Pharma's generic Ethyol
The USA's Caraco Pharmaceutical Laboratories has launched amifostine for injection 500mg on behalf of Indian generic drugmaker Sun Pharmaceutical Industries. The copy version of USA-based MedImmune's injectable cancer drug Ethyol has been added to Caraco's Paragraph IV marketing agreement which Sun Pharma signed on January 29.
Sun recently received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for generic Ethyol and, being the first-to-file, has a 180-day marketing exclusivity. Sun Pharma is currently involved in patent litigation with MedImmune Oncology concerning this product in the US District Court for the District of Maryland.
The agent is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with ovarian cancer. Ethyol had US sales of approximately $80.0 million for the 12-month period ended December 31, 2007, according to IMS Health Data.
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