AstraZeneca and MAP Pharmaceuticals Announce Worldwide Collaboration To Develop and Commercialise Unit Dose Budesonide AstraZeneca and MAP Pharmaceuticals, Inc. announced today an exclusive worldwide agreement to develop and commercialise Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary nebulised formulation of budesonide. UDB is being developed by MAP Pharmaceuticals as a potential treatment for paediatric asthma and is currently in Phase III clinical development. UDB has the potential to be nebulised more quickly and at a lower nominal dose than the commercially available product.
AstraZeneca Responds to FDA Joint Advisory Committees’ Recommendation on Symbicort On 11 December 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) – including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee – completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs).
MedImmune Receives FDA Complete Response Letter on Motavizumab AstraZeneca today announced that MedImmune, its wholly owned biologics business, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab. The CRL is in connection with the Biologics License Application (BLA) for motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease, which was submitted on 30 January 2008. Motavizumab is an investigational monoclonal antibody (MAb).
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