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:5/27/2016)... Amarantus BioScience Holdings, Inc. ... Regenerative Medicine, Neurology and Orphan Diseases, today announced that President & ... upcoming investor conferences: SeeThru Equity MicroCap Conference   ... New York City , NY When: Tuesday, May ... Conference   Where: Grand Hyatt Hotel, 109 East 42 ...
(Date:5/26/2016)... NASHVILLE, Tenn. , May 26, 2016 ... provider of software and analytics, network solutions ... healthcare, today announced it entered into a ... leading provider of outpatient software solutions and ... surgery centers, specialty hospitals and rehabilitation clinics ...
(Date:5/25/2016)... , Germany and GERMANTOWN, ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime Standard: ... licensing and co-development agreement with Therawis Diagnostics GmbH to develop ... be to develop and market PITX2 as a marker to ... high-risk breast cancer patients. "We are pleased to ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 2016 , ... This campaign aims to provide a path to improved education ... control and change. , As nearly 795,000 Americans suffering from a new or recurrent ... Plus, with an estimated 129,000 of these people dying from stroke, it’s become our ...
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses and employees ... stories, courtesy of leaders in the nursing and health care industry. It also ... advocates and associations—namely Jones & Bartlett Learning. , Jones & Bartlett Learning is ...
(Date:5/26/2016)... ... May 26, 2016 , ... Despite last week’s media reports ... Yellen and company to wait until March 2017 for an interest rate increase, according ... Robinson College of Business. , “The Federal Open Market Committee (FOMC) dot charts are ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... and clinical outcomes, hosted members and suppliers for its inaugural Member Conference at ... on their mission of elevating the operational health of America’s healthcare providers. , ...
(Date:5/26/2016)... Florida (PRWEB) , ... May 26, 2016 , ... ... House® Project offering a new model of care for living and healing, celebrated ... core values: Meaningful Life in a Real Home provided by Empowered Staff. , “This ...
Breaking Medicine News(10 mins):