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news.Breckenridge Pharmaceutical has entered into another separate agreement with Helm to develop and manufacture a generic ANDA product.
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Under terms of this new agreement, Breckenridge will submit an abbreviated new drug application (ANDA) to the FDA for the product which will be developed by Helm. The product currently shows US sales of approximately $279 million, and is patent protected until 2011.
The two companies previously announced plans to develop and manufacture a generic tablet ANDA product in December 2007. The product was recently filed with the FDA.