BARR GAINS APPROVAL FOR DDAVP TABLETS

Barr Laboratories has received final approval from the FDA for its generic version of DDAVP (desmopressin acetate) tablets in 0.1- and 0.2-mg dosage strengths. Barr, which plans an immediate launch, is the first company to file an abbreviated new drug application (ANDA) with the FDA for the product, entitling the firm to 180 days of marketing exclusivity. DDAVP tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or pituitary surgery. The drug is also indicated for the management of primary nocturnal enuresis. DDAVP generated sales of $191 million during the 12 months ending April 2005, according to IMS Health data.