Navigation Links
Cornerstone Therapeutics Provides a Response to FDA Warning Letter on Deconsal

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:
Evan Smith/Brian Ritchie

Media Relations Contact:
Robert Stanislaro

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:
(Date:11/26/2015)... 26, 2015 ... ser potential att använda SyMRI för att ... för patienter med multipel skleros (MS) eller ... SyntheticMR AB för att kunna använda SyMRI ... Med SyMRI kan man generera flera konstrastbilder ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
(Date:11/26/2015)... , November 26, 2015 ... addition of the "Radioimmunoassay Market by ... (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic Labs), ... Global Forecast to 2020" report to ... has announced the addition of the ...
Breaking Medicine Technology:
(Date:11/29/2015)... ... November 29, 2015 , ... Khanna Vision Institute based ... of Ophthalmology on November 25th 2015. Peer Certification by the Board is done ... specialty. Certification in Ophthalmology is first obtained after the completion of three years of ...
(Date:11/29/2015)... ... November 29, 2015 , ... Key Housing, a top-rated corporate housing service for ... featured apartment community: Epic. In showcasing this featured apartment community in San Jose, Key ... rental market to efficiently find housing suitable to their needs by showcasing quality housing. ...
(Date:11/28/2015)... ... November 28, 2015 , ... Pixel Film Studios is back again with ... the possibilities are endless. Users have full control over angle of view, speed method, ... users are sure to get heads to turn. , ProPanel: Pulse offers fully customizable ...
(Date:11/27/2015)... ... , ... The rapid speed at which Americans are aging ... is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming more prevalent. ... part of this equation: 80 percent of medical care occurs in the home, ...
(Date:11/27/2015)... ... ... The print component of “Supporting Our Caregivers” is distributed ... Minneapolis, South Florida, with a circulation of approximately 250,000 copies and an estimated ... media strategy and across a network of top news sites and partner media ...
Breaking Medicine News(10 mins):