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Generic Version of Desmopressin Acetate Tablets Cleared by FDA

WOODCLIFF LAKE, N.J., July 5 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE:BRL) today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of DDAVP(R) (Desmopressin Acetate) Tablets, 0.1 mg and 0.2 mg. The Company is the first to file an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of DDAVP Tablets, 0.1 mg and 0.2 mg, and is entitled to 180 days of marketing exclusivity on the product. The Company plans to launch its product immediately.

Barr filed an ANDA for Desmopression Acetate Tablets, 0.1 mg and 0.2 mg, with the FDA in July 2002, and was sued on December 13, 2002, by Ferring B.V. and Aventis Pharmaceuticals, Inc. Ferring manufactures DDAVP(R) Tablets for Aventis, which markets the product in the United States. Barr filed for summary judgment in April 2004 and summary judgment was granted in favor of the Company in February 2005. The court ruled that the patent alleged to cover DDAVP is unenforceable and not infringed by Barr's product. The court's decision ended the 30-month stay on FDA approval of Barr's products, and allowed FDA to approve Barr's product in the normal course. In February 2005, Ferring B.V. filed an appeal of the District Court's decision. Barr might be liable for damages if the District Court is reversed on appeal.

DDAVP Tablets had annual sales of approximately $191 million, based on IMS data for the twelve months ending April 2005.

DDAVP (Desmopressin Acetate) 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.

Source: Barr Pharmaceuticals, Inc.

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