FDA slaps MedImmune with FluMist warning letter
FDA warns MedImmune to fix manufacturing issues, or no additional use approvals for FluMist.
NEW YORK (CNNMoney.com) -- The FDA slapped MedImmune with a warning letter over manufacturing problems with its product FluMist, and barred the company from any further approvals for the vaccine until the problems are resolved.
But for now, MedImmune (up $0.38 to $57.74, Charts) is permitted to continue producing and marketing FluMist, according to the FDA, which said the product's safety and effectiveness is not affected by the manufacturing problems.
"There aren't any problems with the product," said Mary Malarkey, the FDA's deputy director of vaccines. "This is not in any way preventing MedImmune from continuing their production."
FluMist, which accounted for $18 million of the Maryland-based company's $1.3 billion total sales in 2006, is a fast-growing product. But even though MedImmune can continue to sell the vaccine, it can't get FluMist approved for children under five until the manufacturing issues are resolved, the FDA said.
"At this junction we were unable to take action on a pediatric supplement for children age five," said Karen Midthun, deputy director at the FDA's center for biologics, in a Tuesday teleconference with reporters.
Malarkey said the issues in manufacturing, conducted at a British plant, involve bacteria levels, and that a previous investigation conducted by the company "was not adequate for the problem."
"We hope to resolve this as quickly as possible and resume the discussions on the application for [children] under five," said Karen Lancaster, spokeswoman for MedImmune, which is in the process of being acquired by AstraZeneca (up $0.08 to $53.56, Charts) for $15.6 billion.