Sun Pharma announced that it has received tentative approval from US FDA for amifostine for injection 500mg, filed from its site in India.
Amifostine is used as an adjuvant in cancer treatment. Sun Pharma’s amifostine 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.
Ethyol is currently covered under 3 patents-‘471 (July 31,2012), ‘731 (July 31,2012) and ‘409 (Dec 8,2017). Sun Pharma filed an ANDA with para IV certification against all the patents. Medimmune filed a suit against Sun Pharma in the District Court of Maryland. Sun Pharma has filed a motion for summary judgment for non- infringement, a company release said.
Sun Pharma markets this product in India based on the formulation developed at its R&D centre SPARC. Sun Pharma is completely integrated for this product and manufactures the API at its plant in Ahmednagar.