Sun Pharmaceutical receives USFDA approval

Sun Pharmaceutical Industries has informed us that USFDA has granted approval for ANDA to market a generic version of medimmune’s ethyol, amifostine for injection 500mg.

This generic amifostine for injection is therapeutically equivalent to medimmune’s ethyol amifostine for injection 500mg. Ethyol has annual sales of approximately US$ 80 million in the US.

Sun Pharma, being the first-to-file an ANDA for generic ethyol with a para IV certification, has a 180-day marketing exclusivity.

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.