TUESDAY, JUNE 19, 2018

Bavarian says FDA approves Imvamune production in U.S.

KVISTGARD, Denmark — Bavarian Nordic A/S announced March 17 that it has received notification that the U.S. Food and Drug Administration has accepted all the actions taken by the company to address the observations made during its inspection of the manufacturing facilities in 2009.

This was the last step along with the clinical and preclinical data that will be used to potentially support the use of Imvamune following a declared emergency.

Now the company will scale up the production as planned so the 20 million doses will be produced and delivered according to the contract.

"What remains are some administrative procedures that need to get in place. Our firm expectation is that we will start deliveries on this order in the first half of 2010," president and CEO Anders Hedegaard told Reuters.

Bavarian has said it aims to deliver 4 million to 5 million doses of Imvamune to the U.S. authorities this year.

The Danish firm had hoped to begin delivery by the end of 2009.