Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. The Company also announced that it is commencing shipment through Global Pharmaceuticals, Impax’s generic division.

Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: “We are pleased to report the final approval of our ANDA and that we are immediately commencing nation-wide shipment of our generic to FLOMAX®. This represents a significant milestone and opportunity for our Company, having the potential to be our largest product launch to date under Global Pharmaceuticals label. Such an opportunity could not be possible if it weren’t for the substantial effort from many of our employees. Their efforts have been instrumental in preparing us to be positioned to capture as much of the market opportunity as possible within a limited shared exclusivity period.”

As previously announced, in October 2009, the Company reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle U.S. patent litigation related to the Comany’s ANDA for its generic FLOMAX® capsules. The settlement of the litigation provided the Company with the opportunity to launch its generic tamsulosin hydrochloride product on March 2, 2010, prior to the expiration of pediatric exclusivity.

Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX® for the functional symptoms of benign prostatic hyperplasia. According to Wolters Kluwer Health, U.S. sales of FLOMAX® 0.4mg capsules were approximately $2.1 billion for the 12 months ended December 31, 2009.

Source Impax Laboratories, Inc.