Company Watch

Sun gets US FDA nod

Our News Bureau - Mumbai

Sun Pharma announced that US FDA has granted final approval for the company's abbreviated new drug application (ANDA) to market its generic version of Roche's Demadex, torsemide tablets and a generic version of MedImmune's Ethyol, amifostine for injection 500 mg. These generic torsemide tablets are therapeutic equivalents of Roche's Demadex tablets and include four strengths 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately $35 million in the US. Torsemide is a diuretic, indicated for the treatment of oedema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of oedema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents. The company expects to reach the market shortly with these products.

The generic amifostine for injection is therapeutically equivalent to MedImmune's Ethyol amifostine for injection 500 mg. Ethyol has annual sales of approximately $80 million in the US. Sun, being the first-to-file an ANDA for generic Ethyol with a para IV certification, has a 180-day marketing exclusivity. Ethyol is covered under three patents—'471, '731 and '409. This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the district court of Maryland and the case is under litigation. 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.

Along with these approvals Sun also announced that US FDA has granted tentative approval for the company's abbreviated new drug application (ANDA) for its generic version of Eli Lilly's Gemzar, gemcitabine injection. These generic gemcitabine injections come in two strengths, 200 mg and one gram single use vial. These strengths of gemcitabine injections have annual sales of approximately US $680 million in the US. Gemcitabine is an anticancer, used singly or in combination with other anticancer agents.