Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links
BUSINESS - PHARMA - FLU VACCINE FLAURIX

Glaxo applies for FDA approval for Flaurix

GlaxoSmithKline submits biologics license application for FDA approval of Fluarix. New Vaccine Candidate Would Increase Supply of Flu Vaccine in the U.S.

 

BY A CORRESPONDENT

PHILADELPHIA, PA, May 25, 2005: GlaxoSmithKline today announced it has submitted a Biologics License Application for Fluarix TM [Influenza Vaccine (split virion, inactivated)] to the U.S. Food and Drug Administration. If licensed, Fluarix will be used for the active immunization of adults against influenza disease caused by influenza virus types A and B contained in the vaccine. Fluarix will be available exclusively in prefilled TipLok® syringes.

“Right now a limited number of companies supply injectable flu vaccine to the entire nation, making the system vulnerable when there are problems with supply as we saw last flu season,” said Christopher Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline. “We're happy to be once again working closely with the Department of Health and Human Services and the FDA to help fill this void in public health, and with FDA approval, we're committed to making Fluarix available before the next flu season.”

Fluarix is currently available in more than 75 countries.

About Influenza

Influenza is a highly contagious and potentially fatal virus that affects millions of people each year in the U.S. The flu can reach epidemic levels and poses a threat, particularly to the nation’s oldest and youngest citizens. Many respiratory diseases occur every winter but influenza is one of the most severe. Influenza affects 10 to 20 percent of the total U.S. population during seasonal epidemics, resulting in approximately 36,000 deaths in the United States each year.

Influenza is easily passed from one person to another through the air by tiny droplets and particles released when an infected individual coughs or sneezes. Most people recover fully within a week or two. The risk of complications is elevated in very young, very old and chronically ill persons. The genetic makeup of the disease and the rapid mutations that occur make it impossible to eradicate.

“Influenza vaccine is the most important tool we have to control a highly communicable infection that threatens young and old alike,” said Dr. John Treanor, professor of Medicine and of Microbiology and Immunology, University of Rochester School of Medicine and Dentistry, Rochester, New York. “The potential introduction of another supply of safe and effective influenza vaccines is especially welcome now as we try to improve flu vaccination rates in the United States.” 

BY A CORRESPONDENT
 

Pharma News Headlines

Cancer News

Cardiac News

US FDA News

Pharma industry news

LATEST UPDATES

Roche, Novartis lead on novel cancer therapies

US FDA grants fast track status for GSK’s HIV drug

Stem Cell Bill could be delayed in US

FDA warning on abortion drug Mifeprex (Mifepristone)

US FDA recalls Baxter’s intravenous pumps

US FDA grants tentative nod to Ranbaxy’s glimepiride

Lupin launches generic ceftriaxone in US

Hormonal contraceptives safe for long-term use: WHO

Abortion pill to carry 'black box' warning

Vaccines not linked to autism, say experts

Novartis acquires Bristol-Myers’ OTC business in US

Guidant alerts on flaw in pacemakers

Awareness on Medicare drug benefit scheme low in US

NIH review finds govt scientists having ties with pharma firms

US FDA to decide on Plan B morning-after pill by Sept 1

Painkiller patch Duragesic under US FDA probe over patients deaths

Legionnaire's disease outbreak in US hospital in New Rochelle 

Genepharm in pact with 3 Australian distributors 

UK has new generics reimbursement scheme 

Teva gets US FDA nod for mirtazapine anti-depressant 

US patent office rejects Pfizer’s Lipitor claims 

Aethlon Medical to start trials on HIV device in India 

Panel to decide fate of Advair, Serevent and Foradil asthma drugs 

Prohibitive costs mar cancer therapy 

FDA directs Palladone withdrawal

Blindness alert on impotence drugs  

Novartis files for breast cancer drug in US, Europe  

Merck readies for $10 billion Vioxx battle  

Speak up on menopause, campaign urges US women 

Direct-To-Consumer ads mislead patients: US Senator  

EU to decide on sops for developing kids drugs  

Zidovudine by Ranbaxy gets US FDA tentative nod

Parkinson's Disease therapy triggers gambling in some patients

Parkinson's Disease symptoms may be relieved by Azilect

Are obesity and diabetes just accelerated aging?

Reducing lung infection and inflammation due to Cystic Fibrosis

Viruses may help cure cancer by killing cancer cells

New product relieves tooth pain resulting from dental sensitivity 

Cervical Cancer detector may improve on Pap Smears

Dietary supplement capsule by Liqing banned in US

Cold Stone Creamery cake batter ice-creams recalled

Guidant defibrillator recall: US FDA makes three classifications

AIDS drug stavudine by Aurobindo Pharma gets tentative US FDA approval for PEPFAR

Gates Foundation donates for a good cause

Paxil CR resupply in US pharmacies announced by GlaxoSmithKline

Viagra users not at risk of blindness: Pfizer

Stem cell research gets boost from Li Ka-shing

BiDil heart failure drug for black patients approved

Restless leg syndrome could be messing up your sleep

Glaxo Smithkline in pact with IAVI to develop AIDS drug

Pfizer acquires Vicuron Pharma for $1.9 billion

German Remedies launches Fludara Oral

Ranbaxy acquires generic product portfolio from Efarmes

Sandoz files seven ANDAs of drugs going off-patent

Elder Pharma plans unit, brand acquisition

Novasite Pharma buys PsyCheNomicS

Chemokine gets US patent for novel cancer drug

Roche gets USFDA approval for oral Xeloda

Nectar Lifesciences plans Rs 90 crore IPO 

Glaxo inks co-promotion pact with Eisai for Paritec

Early Intervention required to Prevent Diabetes

AIDS drug ahoy!

Novartis launches AMD patient counselling programme

Nanobac Life Sciences, UCSF to study kidney stones 

Surface Logix commences phase I trial for PDE-5 inhibitor

Temasek sets up $112 million pharma JV

Contraceptive from Neem, courtesy DRDO  

US FDA to source anti-HIV drugs from Indian firms  

Chemists boycott Glaxo, Novartis products  

Maharashtra phases out nerve tissue-based rabies vaccine  

Last long, really long - new sex drug soon  

Johnson and Johnson demonstrates coronary stent safety

Novartis has better breast cancer treatment

Pfizer's investigational drug reduces tumor growth

New labeling for beta-blocker Coreg 

Glaxo applies for FDA approval for Flaurix

Investigational drug for Acute Bipolar Mania And Schizophrenia

Preclinical Data Support Link Between IL-9 and Airway Hyperresponsiveness Associated With Asthma

 

 

Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us