The U.S. Food and Drug Administration (FDA) recently approved AstraZeneca's Newark, Del.-based sterile facility to aseptically fill, package and distribute its antibiotic, Merrem® I.V.. Currently, Merrem® I.V. is indicated in the USA for intra-abdominal infections in adults and children, and bacterial meningitis in children three months of age and older. Outside the USA 'Merrem®'is licensed for in a wide range of infections.

Production at the dedicated, 50,000 square foot aseptic filling facility, representing an initial investment of $25m, is well underway. According to the Newark site's Executive Director & General Manager, Ron Matthews, "This state-of-the-art facility has the capacity to meet demand for the U.S. and other world markets for this important medicine."

The Newark sterile facility for Merrem® is located on the same campus as AstraZeneca's manufacturing and distribution facilities for a number of key products such as Nolvadex®, Seroquel®, Arimidex®, and Diprivan®. Prior to the construction of this sterile facility, Merrem® was produced by a contract manufacturer.

"The approval of the Newark sterile facility represents an important step in having greater control over the manufacturing process for Merrem® I.V. We are keenly aware of the need to provide this medicine for those seriously ill patients who do not respond to conventional antibiotics," said C.G. Johansson, president and CEO, AstraZeneca LP.