MedImmune says it resolves FDA FluMist plant issues
WASHINGTON, Sept 7 (Reuters) - Biotech company MedImmune said on Friday it addressed violations raised by U.S. regulators at the British plant that makes its flagship FluMist influenza vaccine.
The company, recently acquired by British drugmaker AstraZeneca Plc (AZN.L), said it resolved the issues raised by the U.S. Food and Drug Administration in a May 2007 warning letter. The FDA had said the firm failed to properly probe contamination problems at the Liverpool plant, although the vaccine did not appear to be tainted.
The facility is the bulk manufacturing plant for FluMist, a nasal vaccine for influenza.
The FDA warning had held up the company's bid to sell FluMist for children under the age of 5 years old. It is now approved for healthy 5-year-old to 49-year-olds and competes with rival injectable flu vaccines made by GlaxoSmithKline Plc (GSK.L) Sanofi-Aventis (SASY.PA) and Novartis AG (NOVN.VX).
MedImmune expects to be ready for shipping the vaccine for the upcoming flu season.
(Reporting by Kim Dixon)
((Editing by Andre Grenon; Reuters Messaging; kim.dixon.reuters.com@reuters.net; email; kim.dixon@reuters.com +1-202 354 5848)) Keywords: MEDIMMUNE FDA/
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