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news.Breckenridge Pharmaceutical, a marketer of generic prescription products, has entered into a new agreement with Helm, a chemical and pharmaceutical organization, to develop and manufacture an abbreviated new drug application for an asthma drug product.
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Under terms of this new agreement, Breckenridge will submit an abbreviated new drug application (ANDA) to the FDA in 2009 for the product which is in development by Helm.
The two companies have previously announced plans to develop and manufacture two other separate ANDA products. The first product was filed with the FDA in early 2008, and the second will be filed in early 2009.