GSK announces revised product labels for Serevent and Advair

Issued: Research Triangle Park, NC 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. 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 Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Claire Brough (020) 8047 5502 Stephen Rea (020) 8047 5502 Alexandra Harrison (020) 8047 5502 Jo Revill (020) 8047 5502 US Media enquiries: Patty Johnson (919) 483 2839 Mary Anne Rhyne (919) 483 2839 European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 Gary Davies (020) 8047 5503 US Analyst/ Investor enquiries: Tom Curry (215) 751 5419 Jen Hill Baxter (215) 751 7002 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. Registered in England & Wales: No. 3888792 Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS Gsk Logo This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our location selector. © 2001-2026 GSK plc. All rights reserved. Trade marks are owned by or licensed to the GSK group of companies. GSK plc. Registered in England and Wales No. 3888792. Registered office: 79 New Oxford Street, London. United Kingdom. WC1A 1DG > Modern Slavery Act Statement 2025 (PDF - 187.7KB) GSK websites Locations selector Social media directory GSKPro for healthcare professionals GSK study register Supplier website ViiV Healthcare Quick links Behind the Science magazine Company Innovation Products Responsibility Investors Media Careers Get in touch Contact us Partnerships Report a possible side effect GSK Speak up Follow us on: Accessibility Digital sustainability Terms of use Cookie policy Privacy notice Sitemap

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