Navigation Links
GSK Announces Revised Product Labels for Serevent® and Advair®
Date:6/2/2010

RESEARCH TRIANGLE PARK, N.C., June 2 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent® and Advair®.  The letter concludes discussions between GSK and the agency following FDA advisory committee meetings regarding the safety profile of long-acting beta2-agonists in the treatment of asthma, including salmeterol, the active ingredient in Serevent and one of the active ingredients in Advair.  The changes communicated by the FDA reflect class labeling for all LABA containing products and are specific to product labels in the U.S.

GSK will work quickly to implement changes described in the FDA's correspondence and communicate these changes to healthcare providers.  

Advair and Serevent remain important treatment options for appropriate patients with asthma and COPD.

For full FDA announcement click here. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. US Oncology Announces iKnowMed(TM) Technology Platform
2. Orexigen® Therapeutics Announces FDA Acceptance of Contrave® New Drug Application for the Treatment of Obesity
3. Dendreon Announces Presentation of PROVENGE Data at the American Urological Association Annual Meeting
4. Elbit Imaging Ltd. Announces First Quarter Results for 2010
5. CardioGenics Announces Update Regarding Status of Merck Agreement
6. Xanodyne Announces Planned President & CEO Succession
7. CSL Behring Announces Completion of National Marketing Authorizations of Berinert® After MRP in 23 European Countries
8. China Yongxin Pharmaceuticals Announces 1-for-12 Reverse Stock Split
9. Amira Announces Second DP2 Antagonist Patent Grant in the United Kingdom
10. Horizon Pharma, Inc. Announces FDA Acceptance of DUEXA(R) New Drug Application for Filing
11. Renhuang Announces Successful Preliminary Review of Its Patent Application for Schisandra Total Lignin Extraction Method
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/5/2017)... , Oct. 5, 2017  In response ... of Oral and Maxillofacial Surgeons (AAOMS) released prescribing ... – to be used as a first-line therapy ... Recognizing the ... AAOMS White Paper "Opioid Prescribing: Acute and Postoperative ...
(Date:10/2/2017)... INDIANAPOLIS , Oct. 2, 2017  Eli Lilly ... its financial results for the third quarter of 2017 ... a conference call on that day with the investment ... performance. The conference call will begin at ... public can access a live webcast of the conference ...
(Date:9/28/2017)... , Sept. 28, 2017 Cohen Veterans Bioscience ... the use of wearable and home sensors for real-time ... Early Signal Foundation, a nonprofit organization focused on disruptive ... provide an affordable analytical system to record and integrate ... ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris ... of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking ... in the field of medical informatics, this prestigious award is presented to an individual ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the Los ... article to the newly revamped Cosmetic Town journal section, featuring articles ... procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi says ...
(Date:10/12/2017)... ... 2017 , ... On Saturday, October 21, the Health & Wellness Center at ... raise money for the American Heart Association Heart Walk. Teams of up to 10 ... to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the United States, single-family ... some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average ... extremely low property-tax rates, which contributes to the relatively lower cost of living ...
(Date:10/12/2017)... ... October 12, 2017 , ... Vodori, Inc., ... promotional review platform at the Promotional Review Committee Compliance and Best Practices ... streamline the medical, legal, and regulatory review (MLR) process – which ensures ...
Breaking Medicine News(10 mins):