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Home Industry News AstraZeneca reports US delay

AstraZeneca reports US delay

1st December 2008

AstraZeneca has reported a delay in receiving a new infant lung drug from its recently acquired MedImmune biotech unit.

The product is due to be marketed in the United States, however the company added it had received a letter from the US Food and Drug Administration (FDA) asking for additional information on motavizumab.

Such a move will delay approval for the antibody drug – which is used for the prevention of serious respiratory syncytial virus – but the organisation said a reponse to outstanding questions could be formulated.

It added it did not expect to undertake any more clinical trials.

AstraZeneca said in a statement: “MedImmune will continue discussions with the FDA reviewers and, subject to this dialogue, currently expects to resubmit in the first half of 2009.”

Last month, AstraZeneca said it is, along with its partner Par Pharmaceuticals, to suspend distribution of the generic version of Pulmicort.

The announcement follows the granting of a temporary restraining order by the US district court for the district of New Jersey, which said to halt sales of the item.

AstraZeneca has over 67,000 employees, of which 55 per cent are in Europe, 30 per cent in the Americas and 15 per cent are in Asia, Africa and Australasia.

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