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news.US drug manufacturer MedImmune has been told by the FDA that compliance issues at the company's UK bulk manufacturing plant will delay the widened approval of its FluMist nasal spray flu vaccine.
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MedImmune submitted the supplemental biologics license application to extend the age application of FluMist to include children under five years of age that do not have a history of asthma or wheezing.
MedImmune said that the FDA had acknowledged the agreed-upon labeling for the vaccine and post-marketing commitments made by the company, but added that the agency has reserved final action on the FluMist supplement until the unspecified compliance issues at the UK plant have been satisfactorily resolved.
“We take the agency’s observations with respect to compliance at our bulk manufacturing plant very seriously and are working to promptly and thoroughly respond to its concerns,” said Linda Peters, senior vice president of regulatory affairs at MedImmune.
Ms Peters added: “We are working with the FDA to ensure timely approval of pending supplements and release of vaccine as planned for the 2007-2008 influenza season.”
MedImmune said that the FDA’s action does not affect the tender offer or the subsequent merger pursuant to which AstraZeneca proposes to acquire the company.