Akorn, Inc. has received approval from the FDA for its supplemental BLA for a unit-dose preservative-free Tetanus Diphtheria vaccine. The company expects to launch the vaccine in 1Q08.
In March 2007, Akorn announced that it had entered into an exclusive distribution agreement with Massachusetts Biologic Laboratories for Tetanus Diphtheria vaccine. Since September 2007, Akorn has been marketing a multi-dose preserved version of the Tetanus Diphtheria vaccine. This new approval will allow Akorn to effectively compete in the estimated $225 million U.S. market, according to the company.