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news.FDA has granted final approval of the Impax Laboratories’ (Impax) abbreviated new drug application (ANDA) for the generic version of Flomax (tamsulosin hydrochloride) 0.4mg capsules. Impax has also initiated shipment of the drug through its generic division Global Pharmaceuticals.
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As previously announced, in October 2009, Impax has reached agreement with Astellas Pharma and Boehringer Ingelheim Pharmaceuticals to settle US patent litigation related to its ANDA for its generic Flomax capsules.
Impax said that the settlement of the litigation provided it with the opportunity to launch its generic Tamsulosin hydrochloride product on March 2, 2010, prior to the expiration of pediatric exclusivity.
Larry Hsu, president and CEO of Impax, 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.”