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

Cornerstone Therapeutics Receives CARDENE(R) I.V. (Nicardipine Hydrochloride) 
Paragraph IV Notice Letter 
CARY, NC -- (Marketwired) -- 06/13/13 --  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(R) 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(R) 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(R) 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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