FDA asks for more info on new Botox indication
The US Food and Drug Administration has delayed approving Allergan's Botox (botulinum toxin type A) for upper limb spasticity in post-stroke adults, but has not asked for more clinical trials to be conducted on the drug, which is already used to treat wrinkles.
Allergan submitted its supplemental Biologics License Application for this indication in the third quarter of 2008. In its complete response letter, the FDA asked for a risk evaluation and mitigation strategy and safety update.
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