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Ipsen and Medicis's Reloxin misses FDA user fee date
16 April 2009
Katie McQue
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16 April 2009
Katie McQue
katie.mcque@informa.com
Ipsen says it is still in discussions with the US FDA over labelling and a risk evaluation and mitigation strategy (REMS) for its botulinum neurotoxin type A product Dysport/Reloxin, resulting in it missing its user fee date of April 13th.
This is the second US delay for Dysport/Reloxin...
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