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news.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.
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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.
Arthur Przybyl, president and CEO of Akorn, said: “This is one of three significant near-term product launches that require FDA approval. The other two products are generic oral vancomycin capsules and Akten, our ophthalmic NDA indicated for ocular procedures that require a topical anesthetic.”