BRIEF-U.S. FDA wants more information on Astra lung drug
LONDON |
LONDON Aug 30 (Reuters) - AstraZeneca says its MedImmune biologics unit has received a request from the U.S Food and Drug Administration for more information on its infant lung drug motavizumab.
The letter from the U.S. medicines regulator asked for evidence from an additional clinical trial that supports a satisfactory risk/benefit profile in the population for which the prophylaxis indication is being requested, Astra said on Monday. (Reporting by Kate Kelland; Editing by Dan Lalor)
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