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Cornerstone Therapeutics Provides a Response to FDA Warning Letter on Deconsal
Date:11/20/2009

CARY, N.C., Nov. 20 /PRNewswire-FirstCall/ -- Cornerstone Therapeutics Inc. (Nasdaq: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today reported that it had received a Warning Letter from the Food and Drug Administration ("FDA") alleging that its Deconsal CT chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg) and Deconsal DM chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg, Dextromothorphan HBr 15 mg) are new drugs lacking an approved application and as such should not be introduced into interstate commerce. Cornerstone is preparing an appropriate response to the FDA.

Cornerstone has not sold any Deconsal CT products since July 2009 and has not sold any Deconsal DM products since January 2009. Net revenues from the sales of the Deconsal products in 2009 year to date are $173,498. Cornerstone does not intend to manufacture, or have manufactured, any further lots of this product.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (Nasdaq CM: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets. The Company currently promotes multiple marketed products in the United States to respiratory-focused physicians and key retail pharmacies with its specialty sales force. The Company also has a late-stage clinical pipeline with a recent regulatory submission filing and four additional regulatory approval submissions targeted within the next three years. Key elements of the Company's strategy are to in-license or acquire rights to underpromoted, patent-protected, branded respiratory or related pharma
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SOURCE Cornerstone Therapeutics Inc.
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