FDA Warning Letter for Deconsal: Cornerstone Therapeutics preparing a response

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.