FDA delays decision on Ipsen over therapeutic issues

Published: 15-Apr-2009

The US Food and Drug Administration (FDA) has deferred a decision on a competitor to Botox developed by the French independent group Ipsen. The FDA was expected to give a ruling on marketing approval by 13 April but Ipsen and its US partner Medicis have said they are still in active discussion with the FDA on issues such as product labelling, risk management and communication.


The US Food and Drug Administration (FDA) has deferred a decision on a competitor to Botox developed by the French independent group Ipsen. The FDA was expected to give a ruling on marketing approval by 13 April but Ipsen and its US partner Medicis have said they are still in active discussion with the FDA on issues such as product labelling, risk management and communication.

The agent could be licensed both for use as a skin cosmetic and as a therapeutic product. Ipsen has said the FDA wants more detail on the therapeutic aspects of the product which is to be commercialised before the end of the year in the UK and Germany by Galderma, the joint Nestlé-L'Oréal company.

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