The US Food and Drug Administration has granted final approval for Teva Pharmaceuticals'ANDA for desmopressin acetate tablets, 0.1 mg and 0.2 mg.
Teva's desmopressin acetate tablets are the AB-rated generic equivalent of Aventis' DDAVP tablets, a product indicated for management of central diabetes insipidus, temporary polyuria and polydipsia following head trauma or surgery in the pituitary region, and primary nocturnal enuresis, claims the company release.
Total annual sales of the product, including brand and generic sales, are approximately $202 million.
Teva is currently in patent litigation concerning this product in the US District Court for the District of Delaware.
Teva Pharmaceutical Industries Ltd is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.