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news.Breckenridge has entered into an agreement with Helm to develop and manufacture a generic tablet abbreviated new drug application product.
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Breckenridge expects to file an abbreviated new drug application (ANDA) with the FDA in January 2008. Upon approval by the FDA, Helm will supply and Breckenridge will market and distribute the product on an exclusive basis.
Under terms of the agreement, Breckenridge will submit an ANDA to the FDA for the product which has been developed by Helm. According to the companies, the product currently shows US sales of approximately $800 million.