AstraZeneca faces a delay in getting a new drug from its recently acquired MedImmune biotech unit to market in the United States. The Anglo-Swedish drugmaker said on Friday it had received a so-called "complete response letter" from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab.
The move will delay approval of the antibody drug for preventing serious respiratory syncytial virus, but the company said it was confident it could respond to the outstanding questions and did not expect to have to conduct further clinical trials.
"MedImmune will continue discussions with the FDA reviewers and, subject to this dialogue, currently expects to resubmit in the first half of 2009," AstraZeneca said in a statement.
AstraZeneca bought MedImmune for $15.6 billion last year to bolster its pipeline of new medicines and increase its presence in the fast-growing biotechnology sector.
Many analysts said at the time it had overpaid for the business.
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