Navigation Links
MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist(R)
Date:9/7/2007

FluMist Expected to Be Available Soon for 2007-2008 Season

GAITHERSBURG, Md., Sept. 7 /PRNewswire/ -- MedImmune announced today that it has resolved the observations made by the U.S. Food and Drug Administration (FDA) during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, United Kingdom. The agency's observations led to the issuance of a Warning Letter on May 24, 2007, which has now been resolved. The UK facility is the bulk manufacturing site for FluMist(R) (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance commitments.

MedImmune is currently working with the FDA on the standard annual lot release process so that shipping of FluMist to customers can soon begin for the upcoming influenza season. MedImmune can now also take the necessary regulatory steps to seek the FDA's final approval of the company's supplemental biologics licensing application requesting expansion of the vaccine's indication to include children below 5 years of age.

About FluMist

FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.

Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune def
'/>"/>

SOURCE MedImmune
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Kenya Resolves to Fight Tuberculosis
2. IIT Delhi Scientist Finds Climate Models Consistent With Ocean Warming Observations
3. Fresh warnings to doctors regarding abortion pill
4. Researchers Present Data Regarding The Efficiency Of Herbs
5. Will anxiety regarding fertility treatment affect the chances of conception?
6. Changing Trends Regarding Insurance Cover For Weight Reduction Surgery
7. Indian Government warns Gujarat regarding possibility of bird flu
8. Leeches Provide Clues Regarding The Prevention Of Heart Disease
9. AIDS control requires co-coordinated move regarding safe sexual practices
10. Legal Action against Authority Regarding Outbreak of Legionnaires’ Diseas
11. Mixed Opinion Regarding Common Medical And Engineering Entrance Test
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... ... July 29, 2015 , ... For the second year ... featured in the list of the 50 fastest growing companies in Jacksonville. This annual ... business community. On July 16th, a team of Vast Bridges staffers were on hand ...
(Date:7/29/2015)... ... 29, 2015 , ... Fastline Publications, Inc., will be featured ... , Fastline is dedicated to quality agricultural advertising, both in print and online. ... freshest searchable agriculture equipment database in the world. The site has equipment listings ...
(Date:7/29/2015)... ... ... Employee Fiduciary, LLC announces the launch of its new, online Financial Advisor ... administered, years in business, and credentials of all Employee Fiduciary financial advisor partners ... Fiduciary. A search can be done by zip code so a plan sponsor can ...
(Date:7/29/2015)... ... July 29, 2015 , ... Zofran lawsuits around ... on Multidistrict Litigation (JPML), according to court documents.* Attorneys handling Zofran lawsuits ... Zofran Birth Defects Lawsuit Center. , GlaxoSmithKline, the global pharmaceutical conglomerate and defendant ...
(Date:7/29/2015)... ... July 29, 2015 , ... National non-profit World ... life insurance, annuities, employee benefits and asset management, has joined as presenting sponsor ... taking place in Charlotte, North Carolina on October 2-4, 2015. , Hosted at ...
Breaking Medicine News(10 mins):Health News:Vast Bridges Continues Its Swift Growth 2Health News:Fastline Publications to Partner with American Farmer in Upcoming Episode Airing on RFD-TV 2Health News:Employee Fiduciary Launches Financial Advisor Directory 2Health News:Zofran Lawsuit News: Zofran Lawsuits Stayed, Awaiting MDL Decision 2Health News:Zofran Lawsuit News: Zofran Lawsuits Stayed, Awaiting MDL Decision 3Health News:Zofran Lawsuit News: Zofran Lawsuits Stayed, Awaiting MDL Decision 4Health News:MetLife Joins World T.E.A.M. Sports’ Adventure Team Challenge North Carolina as Presenting Sponsor 2Health News:MetLife Joins World T.E.A.M. Sports’ Adventure Team Challenge North Carolina as Presenting Sponsor 3
... HR summit for organizations in SE Michigan ... and HR professionals. Increase wellness, decrease insurance costs, ... Mich., May 4 Cambridge Employee Benefits, a ... fourth annual corporate Wellness & HR Summit May ...
... American Red CrossCHICAGO, May 4 As school districts ... swine flu (H1N1 flu outbreak), millions of parents are ... In response to this recent flu outbreak, Sittercity.com ... for the month of May. With over a ...
... and supporting 6 million stroke survivors in the United States. , ... ... a stroke, leaving a path of destruction that affects millions of lives ... is observing National Stroke Awareness Month in May. Organizations, including Allsup ...
... help people decide if they have the flu and what they should do. ... ... doctor to help people decide if they have the flu and what they ... epidemic, consumers are on their own when making the decision to see a ...
... parents do not consider furniture and televisions to be ... over. A recent study conducted by the Center for ... Nationwide Children,s Hospital found that from 1990-2007 an average ... age visited emergency departments annually for injuries received from ...
... Acclarent, Inc., the pioneer of Balloon Sinuplasty ... sinusitis, announced today that the U.S. Patent and Trademark ... and Methods for Treating Disorders of the Ear, Nose ... Acclarent,s earlier 7,462,175 patent are directed to methods for ...
Cached Medicine News:Health News:Cambridge Employee Benefits to Host Corporate Wellness & HR Summit 2Health News:In-Home Caregivers Standing by Nationwide to Support Increased Need Due to Swine Flu 2Health News:Four of Five Families Will Be Touched by Stroke in 2009 2Health News:Don't Panic: FreeMD Virtual Doctor Helps Decide If You Have the Flu 2Health News:Study: Furniture tip-over injuries rising 2Health News:Study: Furniture tip-over injuries rising 3Health News:Study: Furniture tip-over injuries rising 4Health News:Acclarent, Inc. Granted Key Patent Covering Balloon Sinuplasty(TM) Technologies 2
(Date:7/28/2015)... ACTON, Mass., July 28, 2015  Psychemedics Corporation (NASDAQ: ... for the period ended June 30, 2015.  The Company ... payable to shareholders of record as of August 7, ... will be the Company,s 76 th consecutive quarterly ... ended June 30, 2015 was $7.0 million versus $7.7 ...
(Date:7/28/2015)... 2015  Nevro Corp. (NYSE: NVRO ), ... innovative evidence-based solutions for the treatment of chronic ... results in the Online First edition of ... of Anesthesiologists. The SENZA-RCT pivotal ... first to directly compare spinal cord stimulation (SCS) ...
(Date:7/28/2015)... 28, 2015  PD-Rx Pharmaceuticals, Inc., a publicly ... has partnered with Dobson Technologies, a fully-integrated outsourced ... (IaaS) product. PD-Rx is an Application ... United States.  Using Dobson Technologies, IaaS solution will ... continuity, ensure regulatory compliance, and reduce operating expenses.  ...
Breaking Medicine Technology:Psychemedics Corporation Announces Second Quarter Earnings 2Psychemedics Corporation Announces Second Quarter Earnings 3Psychemedics Corporation Announces Second Quarter Earnings 4Psychemedics Corporation Announces Second Quarter Earnings 5Psychemedics Corporation Announces Second Quarter Earnings 6Psychemedics Corporation Announces Second Quarter Earnings 7Psychemedics Corporation Announces Second Quarter Earnings 8Nevro Announces Publication of SENZA-RCT Results in Anesthesiology 2PD-Rx Partners With Dobson Technologies 2
... Almost Invisible, SHELTON, Conn., Sept. 2 ... its revolutionary new open-ear hearing,device., Hearing aids ... the,ear canal, causing a person,s voice to sound ... revolutionized the hearing aid industry in April,2004 with ...
... at possible outcomes for older hip patients, ... States along with,the rest of the Western population ... become a more serious concern for patients, families, ... following,hip replacement surgery, but the extremely elderly hip ...
Cached Medicine Technology:Unique Hearing Aid Receives Patent Protection 2Video: Prognosis Split for Hip Fracture and Hip Replacement in the Elderly 2
... Vitatron Excellence PS+ lead series ... to combine the best characteristics ... materials. The polyurethane outer insulation ... and high lubricity while the ...
CapSure SP Novus endocardial, tined pacing leads provide the stable, low pacing thresholds and large sensing potentials already proven with CapSure SP steroid-eluting leads but within an even smaller...
... The IsoFlex S lead's small ... ease implantation and lower the ... smaller, more tortuous vessels. Atrial ... and fixation options combine to ...
The Guidant Fineline II Sterox Atrial J is a steroid-eluting pacing lead designed for permanent implantation for either atrial or ventricular applications....
Medicine Products: