Israel : TEVA bags approval from FDA to market generic asthma treatment … – Equities.com


MedPage Today

Israel : TEVA bags approval from FDA to market generic asthma treatment
Equities.com
US Food and Drug Administration (FDA) have given its approval to Teva Pharmaceutical Industries Ltd. for generic versions of asthma and allergies treatment Singulair in adults and children. Made by Merck & Co., brand Singulair has $5 billion in annual
New generic Singulair could save asthma sufferers big bucksConsumerReports.org
Generic Singulair ApprovedWebMD
FDA approves generic versions of asthma, allergy drugDrug Store News
MedPage Today –RTT News –Jerusalem Post
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First generic versions of Singulair receive FDA approval for treatment of … – News-Medical.net


MedPage Today

First generic versions of Singulair receive FDA approval for treatment of
News-Medical.net
The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Montelukast is in
Teva asthma, allergy drug approved by FDAJerusalem Post
FDA Approves Generic Versions Of Singulair To Treat Asthma, AllergiesNASDAQ
Generic Singulair ApprovedWebMD
MedPage Today –Chicago Tribune –Columbus Dispatch
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Watson gets FDA approval for generic asthma drug – Businessweek

Watson gets FDA approval for generic asthma drug
Businessweek
PARSIPPANY, N.J. (AP) — Generic drugmaker Watson Pharmaceuticals Inc. said Wednesday it received U.S. approval for its generic version of Pulmicort, an inhalable drug used to treat cough and breathing problems caused by asthma and lung disease.
FDA approves Watson asthma genericDrug Store News
Watson's Generic Version of Pulmicort RESPULES® Receives FDA ApprovalMarketWatch (press release)

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GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with … – The Pharma Letter

GSK and Theravance file for FF/VI approval in the USA and Europe; Talks with
The Pharma Letter
Asthma (100/25mcg and 200/25mcg): The regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate. • COPD (100/25mcg): The
GSK, Theravance seek approvals for FF/VI in US, EuropePharmaceutical Business Review
GSK and Theravance file next-generation Advair in USA, EUPharma Times

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GSK, Theravance seek FDA, European approval of COPD/asthma drug – Upstart (blog)

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SkyePharma soars on asthma drug approval – Telegraph.co.uk

SkyePharma soars on asthma drug approval
Telegraph.co.uk
By Rachel Cooper, City Reporter SkyePharma has been hurt by concerns over its asthma therapy, Flutiform, with the share price taking a tumble just before Christmas as traders learnt of another delay to its European approval.
SkyePharma asthma drug wins European backingReuters UK
SkyePharma's asthma drug wins European backingLondon South East

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GSK to seek approval of Theravance lung drug – San Francisco Business Times (blog)

GSK to seek approval of Theravance lung drug
San Francisco Business Times (blog)
GlaxoSmithKline will seek approval of the COPD drug Relovair in the United States and Europe in mid-year, and it and partner Theravance Inc. will continue to talk to regulators about also using the drug for asthma patients.
GSK and Theravance Announce Initial Outcomes From Pivotal Phase III Studies MarketWatch (press release)
Glaxo set to submit Relovair to regulatory authoritiesShareCast
GSK aims to file new lung drug Relovair in mid-2012Reuters UK
Capital.gr (press release)
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SkyePharma’s Asthma Treatment Faces European Approval Delay; Shares Fall – RTT News

SkyePharma's Asthma Treatment Faces European Approval Delay; Shares Fall
RTT News
PK: News ) plunged on the London Stock Exchange in Tuesday morning trade, after the British drug delivery specialist reported a delay in review of the European Marketing Authorisation Application or MAA for its asthma therapy Flutiform due to lack of
SkyePharma lung drug faces European approval delayReuters UK

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Skyepharma banking on European approval for Flutiform – Stock Market Wire

Skyepharma banking on European approval for Flutiform
Stock Market Wire
The group said it was counting on European approval of asthma treatment Flutiform and launch in the second half of 2011. Revenue was up 4% to £58.1m from £55.9m, in line with management expectations. The rise was primarily due to a substantial increase
SkyePharma Moves To 2010 Pretax Profit, Sees Cash OutflowsWall Street Journal
STOCKS NEWS UK-SkyePharma up on results Flutiform optimismLondon South East
Skyepharma turns in annual profitShareCast

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