Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Barr Laboratories has received final approval from the FDA to market its generic version of DDAVP, an antidiuretic marketed by Sanofi-Aventis.
Subscribe to our email newsletter
Barr Laboratories, a subsidiary of Barr Pharmaceuticals, is the first company to file an application to the FDA for a generic version of DDAVP (desmopressin acetate) 0.1mg and 0.2mg tablets, and is entitled to 180 days of marketing exclusivity on the product. The company plans to launch its product immediately.
The original FDA application was filed in July 2002. Barr was subsequently sued by Ferring BV and Aventis Pharmaceuticals, the manufacturers and marketers of the product in the US. Summary judgment was granted in favor of Barr in February 2005, allowing its application to be considered.
Ferring has since filed an appeal, meaning that Barr might still be liable for damages if the decision is reversed.
Barr said that DDAVP tablets had annual sales of approximately $191 million for the twelve months ending April 2005.
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 surgery in the pituitary region. They are also indicated for the management of primary nocturnal enuresis.