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VIG product submitted for FDA approval.
2004 SEP 1 - (NewsRx.com & NewsRx.net) -- Cangene announced that it has submitted a biological license application (BLA) to the U.S. Food and Drug Administration (FDA) for Cangene's Vaccinia hyperimmune globulin (VIG).
Cangene's application has been given Fast Track designation by the FDA, which is a program designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
The Fast Track designation also allows for a rolling review of the BLA, allowing Cangene to submit data as the trial progresses. Cangene has already manufactured VIG under a 5-year supply and development agreement with the United States Centers for Disease Control and Prevention (CDC) that began 2 years ago.
VIG is a hyperimmune product to be used in treating and preventing a type of severe reaction that may be brought on by the administration of the smallpox vaccine and is an important component to ...
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