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Cornerstone Therapeutics Inc. Receives CARDENE(R) I.V. (Nicardipine Hydrochloride) Paragraph IV Notice Letter


6/13/2013 10:04:55 AM

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CARY, NC--(Marketwired - June 13, 2013) - Cornerstone Therapeutics Inc. (NASDAQ: CRTX) ("Cornerstone" or the "Company") today announced that on June 11, 2013 the Company received a Paragraph IV Notice Letter from Exela Pharma Sciences, LLC ("Exela") advising the Company of the filing by Exela of a supplemental New Drug Application seeking approval for a ready to use injectable formulation of 0.1 mg/mL and 0.2 mg/mL nicardipine hydrochloride in 0.9% sodium chloride. The Company markets a ready to use injectable formulation of 0.1 mg/mL and 0.2 mg/mL nicardipine hydrochloride in 0.86% and 0.83% sodium chloride, respectively, under the name CARDENE® I.V. (nicardipine hydrochloride) Premixed Injection.

Cornerstone is currently reviewing the details of this Notice Letter and will pursue all available legal and regulatory avenues in defense of CARDENE® I.V. (nicardipine hydrochloride) Premixed Injection, including enforcement of their intellectual property rights and approved labeling.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of historical fact, including our strategy and our future operations and opportunities, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including our ability to satisfy FDA and other regulatory requirements, our ability to develop and maintain the necessary sales, marketing, supply chain and distribution capabilities to successfully commercialize our products, our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 14, 2013 and in our subsequent filings with the SEC. In addition, the statements in this press release reflect our expectations and beliefs only as of the date of this release. We anticipate that subsequent events and developments may cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as may be required by law. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.

Trademarks

CARDENE® I.V. is a registered trademark of EKR Therapeutics, Inc., Cornerstone Therapeutics' wholly-owned subsidiary.


Contacts

Investor Relations Contact:
Josh Franklin
Vice President, Strategy and Business Development
+1-919-678-6520
josh.franklin@crtx.com

Media Relations Contact:
Fleishman-Hillard
Andrea Moody
+1-919-457-0743
andrea.moody@fleishman.com



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