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A new infant lung drug may be delayed coming on to the US market because the country’s Food and Drug Administration (FDA) has requested more information about the medicine before giving approval.
Pharmaceutical firm AstraZeneca said that the FDA had requested more information on Motavizumab, a drug used to prevent respiratory syncytial virus – a type of lung infection in babies.
AstraZeneca had hoped that Motavizumab would be on the market in the second half of next year, in time to catch the next winter flu season.
It now plans to answer the FDA’s questions before the end of the first half of 2009, but it is unclear whether that will give the company enough time to get the drug to market on time.
AstraZeneca spokeswoman Sarah Lindgreen said: “We’re not yet speculating on what impact it will have on a possible launch date.”
However, analysts are widely unconcerned about the potential delay’s impact on the company’s sales because a current drug used to prevent respiratory syncytial virus – Synergis – is also produced by the AstraZeneca.
Copyright Press Association 2008
