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Barr Pharma confirms patent challenge of UROXATRAL

Tue Sep 25, 2007 11:19am EDT

Co confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Sanofi- Aventis (SNY) U.S. in connection with its UROXATRAL, 10mg. Barr's Abbreviated New Drug Application containing a paragraph IV certification for a generic UROXATRAL product was received as acceptable for filing by the FDA on June 12, 2007, the first date the FDA could accept an ANDA with a paragraph IV certification for this product. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application and patent holder.



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