Sun Pharmaceutical Industries has announced that the FDA has granted approval for the abbreviated new drug application to market amifostine for injection 500mg.
Amifostine is used as an adjuvant in cancer treatment. Sun Pharma’s amifostine for injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.
This generic amifostine for injection is therapeutically equivalent to MedImmune’s Ethyol amifostine for injection 500mg. Sun Pharma, being the first-to-file an abbreviated new drug application (ANDA) for generic Ethyol with a para IV certification, has a 180-day marketing exclusivity. Ethyol is covered under three patents. This ANDA was filed with para IV certification against all the patents. Medimmune has filed a suit in the District Court of Maryland and the case is under litigation.
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