AstraZeneca faces a delay in marketing its asthma drug Symbicort to young children in the United States after the Food and Drug Administration asked for more information.
The medicine is already approved for patients aged 12 and over and the company is now seeking to sell it for the long-term maintenance treatment of asthma in 6-11 year-olds.
But the U.S. watchdog said AstraZeneca had not provided adequate data to establish the appropriate dose or doses of the drug's two components -- budesonide and formoterol -- in this younger age group.
As a result, the FDA has issued it with a so-called Complete Response Letter (CRL).
"AstraZeneca is evaluating the CRL and will provide a response to the agency in due course," the Anglo-Swedish company said in a statement on Monday.
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