Breckenridge announced today that it has entered into another separate agreement with Helm AG to develop and manufacture a generic ANDA product. Under terms of this new agreement, Breckenridge will submit an ANDA to the U.S. Food and Drug Administration (FDA) for the product which will be developed by Helm AG. The product currently shows U.S. 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 U.S. Food and Drug Administration (FDA).
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