Asthma treatment

31. The News & Observer – August 26, 2000 Glaxo gets FDA go-ahead to sell its new asthma drug RESEARCH TRIANGLE PARK — Glaxo Wellcome won U. S. Food and Drug Administration approval to sell its Advair inhaled asthma drug, the first treatment to combine the two most popular types of asthma medication. The approval for Advair, which is expected to post blockbuster sales, was announced a day after the FDA announced that it had ordered Glaxo to attach to every bottle of its Lotronex medication for irritable bowel syndrome a plain-English pamphlet explaining the risk of severe intestinal ….. – March 6, 2006 Advair and a second GlaxoSmithKline asthma drug get stronger warning labels The asthma medication Advair and a related drug will bear stronger warnings of an increased risk of death associated with one of their ingredients. The revised warnings apply to Advair and Serevent, Food and Drug Administration spokeswoman Laura Alvey said Monday. Advair is GlaxoSmithKline’s best-selling product, and Serevent is another of the British company’s drugs. The updated versions of the “black-box” warnings on both drugs ….. – March 6, 2006 Advair and a second GlaxoSmithKline asthma drug get stronger warning labels The asthma medication Advair and a related drug will bear stronger warnings of an increased risk of death associated with one of their ingredients. The revised warnings apply to Advair and Serevent, Food and Drug Administration spokeswoman Laura Alvey said Monday. Advair is GlaxoSmithKline’s best-selling product, and Serevent is another of the British company’s drugs. The updated versions of the “black-box” warnings on both drugs ….. New York Times, The (NY) – December 6, 2008 Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs — Advair, Symbicort, Serevent and Foradil. But the officials’ views are not universally shared within the government. The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency’s Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A …. 35. wire (USA) – December 27, 2006 GSK Implements Strategic Initiatives to Help Ensure Continuing Strong Sales of Advair, Creation of Dedicated COPD Sales Team and Filing of Data From the Torch Study Could Result in an Increase in Advair Sales The New Brands & Strategies: Asthma Report Reveals Critical Commercial Analysis at the Market, Company, and Brand Level PRNewswire — Decision Resources and Millennium Research Group have produced a new report that finds that GlaxoSmithKline (GSK) has implemented strategic initiatives to help ensure continuing strong sales of Advair. The respiratory area is expected to continue to be GSK’s leading therapeutic area throughout the forecast period due largely to continuing strong sales of Advair; however, the relative contribution of asthma sales to the company’s respiratory segment could ….. wire (USA) – November 18, 2005 GSK Statement on FDA Proposed Labeling Change for Serevent and Advair PRNewswire — GlaxoSmithKline disagrees with the FDA’s proposed product labeling changes for Serevent and Advair, because they are inconsistent with established NIH treatment guidelines and the standard of care for asthma treatment, which could put many patients at risk of uncontrolled asthma. The proposed changes are a departure from recent outcomes of a July 2005 FDA advisory committee meeting that reinforced the favorable benefit-to-risk profile of both medicines. The ….. Datamonitor – December 3, 2008 GSK/Theravance: time is of the essence for Advair successor, Positive Phase IIb results of novel asthma/COPD drug, but competition looms closer. Having achieved successful results in a Phase IIb trial, GlaxoSmithKline is set to progress the development of its once-daily ICS/LABA combination product, which is currently being referred to as ‘Beyond Advair’. However, even if trials progress rapidly, Beyond Advair’s launch is still expected to lag behind those of generic fluticasone/salmeterol and new competitors. GlaxoSmithKline and Theravance have announced positive results from the Phase ….. , The (NC) – September 2, 2008 ASTHMA DRUG ADVAIR CAN RESULT IN SKIN WOUNDS AND BRUISING FOR SOME Q. I was prescribed Advair for asthma. It worked well for my breathing problem, but my skin became thin, and I started bruising badly. Then I experienced horrible damage to my skin, with deep gashes from a slight bump. My lung specialist insisted Advair was not responsible for thinning skin. I asked my pharmacist, and she said, “It could be from taking steroids. ” She checked my meds and told me Advair contains a steroid. I spoke to my doctor, but he still said it was not ….. Orlando Sentinel, The (FL) – March 7, 2006 Asthma drugs get stronger warnings The revised labels on Advair and Serevent warn of an increased risk of death. WASHINGTON — The asthma medication Advair and a related drug will bear stronger warnings of an increased risk of death associated with one of their ingredients. The revised warnings apply to Advair and Serevent, Food and Drug Administration spokeswoman Laura Alvey said Monday. Advair is GlaxoSmithKline’s best-selling product, and Serevent is another of the British company’s drugs. The updated versions of the “black-box” warnings on both ….. (TX) – December 12, 2008 Limits urged on 2 long-acting asthma drugs FDA advisers spare Advair but say Foradil, Serevent should not be used WASHINGTON – Government health advisers Thursday called for restrictions on some long-acting asthma drugs, but spared Advair, a top-selling medication used by millions of patients. Outside experts advising the Food and Drug Administration recommended that Foradil and Serevent no longer be used for asthma. But they said the benefits of Advair and Symbicort clearly outweigh the risks. All the medications contain an ingredient that relaxes muscles around stressed airways …..