Item 7.01 Regulation FD Disclosure.

On October 12, 2012, the U.S. Food and Drug Administration (the "FDA") approved the New Drug Application by Chiesi Farmaceutici S.p.A, Cornerstone Therapeutics Inc.'s (the "Company") majority stockholder, for Bethkis®, an inhaled tobramycin-based product indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa (the "Product"). The Company and Chiesi are currently in final discussions concerning the potential licensing of the Product to the Company in the United States. The terms and conditions of any such license are subject to review and approval by the Audit Committee of the Company's Board of Directors, pursuant to the terms of the Company's Related Person Transaction Policy.

As a result of extensive discussions and analysis of a proposed license transaction in 2011, the Company agreed to permit Chiesi to reference the Company as the labeler in the draft Bethkis labeling Chiesi previously submitted to the FDA. Delays in the approval of Bethkis resulted in the Company deciding not to proceed with a licensing transaction for Bethkis in 2011, and there can be no assurance that the Company and Chiesi will be able to agree upon the terms of a definitive license agreement, nor how long such negotiations may take. In the event that the Company and Chiesi are not able to agree upon the terms of a definitive license agreement, the Company has acknowledged to Chiesi that it will have no right or obligation with respect to Bethkis, and Chiesi has agreed to take immediate steps to identify a replacement labeler.

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