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:10/12/2017)... DIEGO , Oct. 12, 2017 AVACEN ... recognized the company with their  2017 New Product Innovation Award ... based on extensive primary and secondary medical device market research ... Medical, through its first-to-market OTC, drug-free pain relief product, the ... unique approach to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... Calif. , Oct. 11, 2017  BioPharmX Corporation ... scientific team that developed an innovative way to use ... of the delivery of new drugs. ... Fall Clinical Dermatology Conference will show how researchers from ... Hospital, Harvard Medical School used a suite of imaging ...
(Date:10/11/2017)... CHICAGO , Oct. 11, 2017  Hill-Rom Holdings, ... its Aspen Surgical facility in Las Piedras, ... surgical scalpels and blades. ... confirmed that the facility sustained minor structural damage, temporary ... Hurricane Maria. Repairs have been completed, manufacturing operations have ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
(Date:10/12/2017)... WAUSAU, Wis. (PRWEB) , ... October 12, 2017 ... ... formulated standard products to meet the demand of today’s consumer and regulatory authorities ... team of probiotic experts and tested to meet the highest standard. , ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized ... have expanded their existing home health joint venture through an agreement, effective October ... a joint venture home health company with Asante, delivering clinically integrated care, for ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare ... Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during ... , The annual award competition recognizes editorial and design excellence across a range of ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... named one of Michigan’s 2017 Best and Brightest in Wellness® by Best and ... Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 p.m. ...
Breaking Medicine News(10 mins):