Resources for Food and Drug Administration (FDA)

Akorn receives FDA approval for tetanus diphtheria vaccine

www.pharmaceutical-business-review.com

The FDA has approved Akorn's supplemental biologics license application for a unit dose preservative-free tetanus diphtheria vaccine. Akorn expects to launch this new vaccine in the first quarter of 2008.

The approval will allow Akorn to effectively compete in a market estimated to be worth $225 million in the US.

In March 2007, Akorn announced that it had entered into an exclusive distribution agreement with Massachusetts Biologic Laboratories for a tetanus diphtheria vaccine. Since September 2007, Akorn has been marketing a multi-dose preserved version of the vaccine.

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