Navigation Links
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 pharmaceutical products or late-stage product candidates; implement life cycle management strategies to maximize the potential value and competitive position of the Company's currently marketed products, newly acquired products and product candidates that are currently in development; grow product revenue through the Company's specialty sales force, which is focused on the respiratory and related markets; and maintain and strengthen the intellectual property position of the Company's currently marketed products, newly acquired products and product candidates.

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 statements regarding the progress and timing of our product development programs and related trials, 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 the results of preclinical studies and clinical trials with respect to our products under development, our ability to satisfy FDA and other regulatory requirements 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 26, 2009 and in our subsequent filings with the SEC. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release, should not be relied upon as representing our views as of any other date and 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. We anticipate that subsequent events and developments will 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.



Investor Relations Contacts:
FD
Evan Smith/Brian Ritchie
212-850-5600
evan.smith@fd.com/brian.ritchie@fd.com

Media Relations Contact:
FD
Robert Stanislaro
212-850-5600
robert.stanislaro@fd.com


SOURCE Cornerstone Therapeutics Inc.


'/>"/>
SOURCE Cornerstone Therapeutics Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cornerstone Pharmaceuticals Adds Acclaimed Cancer Research Pioneer Robert A. Weinberg, Ph.D. to Its Scientific Advisory Board
2. Echo Therapeutics Announces Positive Results of a Clinical Study Testing Symphony(TM) tCGM System in Patients with Type 1 and Type 2 Diabetes
3. Mersana Therapeutics Provides Clinical Update from Ongoing Phase 1 Study of XMT-1001 in Patients with Advanced Solid Tumors
4. Oxygen Biotherapeutics, Inc. Begins Shipping Cosmetic Product to Customers
5. Paloma Pharmaceuticals Presents at the AACR-NCI-EORTC International Conference Molecular Targets and Cancer Therapeutics
6. Senesco Presents Pre-Clinical Stability and Biological Activity Data on SNS-01 at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
7. Orexigen(R) Therapeutics to Speak at Lazard Capital Markets Healthcare Conference
8. Tobira Therapeutics Announces Presentation of TBR-652 Data at European AIDS Conference
9. Reportlinker Adds Pain Therapeutics 2005: Market Dynamics and Outlook
10. Oxygen Biotherapeutics, Inc. Announces 1:15 Reverse Stock Split to Take Effect Nov. 9, 2009
11. Trius Therapeutics Files Registration Statement for Proposed Initial Public Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/18/2017)... , April 18, 2017 Research and ... Market 2017-2021" report to their offering. ... The global arthroscopy devices market to grow at a ... report, Global Arthroscopy Devices Market 2017-2021, has been prepared based on ... covers the market landscape and its growth prospects over the coming ...
(Date:4/18/2017)... SUNNYVALE, Calif. , April 18, 2017 /PRNewswire/ ... results of collaboration started in 2016, in which ... "Artificial Brain SOINN". The companies achieved initial results ... ultrasound solution by Artificial Brain SOINN. The results ... Tokyo Big Sight, April 19-21, at booths 4505 ...
(Date:4/18/2017)... , April 18, 2017 Recursion ... biological science with machine learning techniques to discover treatments ... Dr. Yolanda Chong as vice president of ... Johnson & Johnson in Belgium , ... that focused on applying high-dimensional biological approaches to the ...
Breaking Medicine Technology:
(Date:4/24/2017)... (PRWEB) , ... April 24, 2017 , ... “The Saint ... Saint with Trin, and Omega Station” is the creation of published author, Chris Jackson. ... Dallas Metroplex where he works in the Dallas Independent School District teaching English. He ...
(Date:4/24/2017)... ... April 24, 2017 , ... Anaconda BioMed, a pre-clinical stage ... the treatment of Acute Ischemic Stroke (AIS), today announced it has appointed Creganna ... advances towards regulatory and clinical phases. , "This is another important step for ...
(Date:4/22/2017)... ... April 22, 2017 , ... Ecommerce sales have grown every year since ... $394.9 billion. The consequences of rapid innovation and growth are often neglected in ... it is every business and individual’s job to give something back to the planet ...
(Date:4/22/2017)... ... ... San Juan Capistrano summer camp team at the Boys and Girls Club of ... to provide physical activities for all campers. To read the report, click here ... increase in specialty camps that focus on what the report terms as “sitting subjects” like ...
(Date:4/21/2017)... Boston, MA (PRWEB) , ... April 21, 2017 ... ... Boston University professor Christopher Salas-Wright finds that youth violence is declining—and at noteworthy ... in the relative proportion of young people involved in violence in the United ...
Breaking Medicine News(10 mins):