Posted on 06/01/2010 in Pharmaceutical Company Product News AstraZeneca's biologics unit MedImmune has filed its formal regulatory response to a complete response letter (CRL) from the Food and Drug Administration (FDA) regarding Motavizumab.
The CRL relates to AstraZeneca's biologics licence application for the drug for the prevention of serious respiratory syncytial virus in infants who are identified as "high-risk".
It was submitted to the FDA in January 2008 and MedImmune received a request for more information regarding the therapy, which is an investigational monoclonal antibody, in November 2008.
No further clinical trials needed to be carried out in the creation of the response.
"The company has been in ongoing discussions with FDA reviewers since then to complete and file its CRL reply," the AstraZeneca unit said, noting that it will continue discussions with the administration's reviewers as necessary until the registration process is completed.
Last month, AstraZeneca announced that it is to collaborate with Forest Laboratories on the future commercialisation and co-development of two antibiotic development programmes - ceftaroline/NXL-104 and ceftazidime/NXL-104.Other news stories from 06/01/2010
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