The American Food and Drug Administration (FDA) have created a delay for the marketing of Symbicort, which is a medication, aimed at young asthma sufferers. [Asthma in children]
The English company AstraZeneca, stated that the FDA is seeking further details before they grant approval for Symbicort’s extended use for even younger children.
Currently it is sanctioned for over twelve age group and is one of its best selling drugs.
AstraZeneca is actually a leading pharmaceutical group in the UK Market place and the FDA’s decision had a negative effect on the share price of the company’s stock. In 2008 two billion dollars worth of Symbicort was sold and it was seen as a key product in an upcoming US sales drive.
In the United States the equivalent asthma medicine is Advair, which is made by GlaxoSmothKline. The latter is widely used in children and can be prescribed to those as young as four years old. Furthermore, Advair is used by people experiencing serious ailments such as emphysema.
The reason for the FDA’s concern is that they feel that AstraZeneca failed to give sufficient data that establishes the correct dosage, in particular the advised dose of the different components when given to individuals.
This is a second set back for AstraZeneca’s who were also hit recently by a FDA announcement voicing worries over the pharmaceutical companies anti-depressant, Seroquel being more commonly prescribed.
There was some good news though as authorities in Sweden agreed to the sale of 220 million dollars worth of products to their big rival GlaxoSmithKline.