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FDA rules asthma drug data 'inadequate' for approval
06 Apr 2009
Regulatory Affairs
AstraZeneca has been informed that its application for approval of asthma treatment Symbicort does not include sufficient data for deciding the appropriate dose.
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the pharmaceuticals company, in which it says that there is not enough information to establish suitable doses for individual components of the drug, budesonide and formoterol.
It adds that the data is insufficient for the authority to determine how these elements will contribute to the combination product.
"AstraZeneca is evaluating the CRL and will provide a response to the agency in due course," the company states.
The firm is seeking approval of the Symbicort inhaler for use by children aged six to 11, following authorisation for the treatment for asthmatic adolescents aged 12 and over.
Earlier this month, the FDA determined that AstraZeneca and Bristol-Myers Squibb's application for its type-two diabetes drug included sufficient information to rule out "unacceptable cardiovascular risk".
