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US FDA requests more data on Organon's Follistim-AQ.

Pharma Marketletter

| July 14, 2003 | COPYRIGHT 2009 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Dutch firm Akzo Nobel's human pharmaceutical business unit Organon says that the US Food and Drug Administration has requested additional data for its fertility product Follistim-AQ (follitropin beta) Cartridge. The agency has informed Organon that the product is non-approvable at this time and, to address its request, a meeting has been arranged with the FDA for some time in the next few weeks.

Follistim-AQ Cartridge is the ready-to-use version of Organon's fertility product Follistim, which it currently markets in the USA. Follistim…

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Source: HighBeam Research, US FDA requests more data on Organon's Follistim-AQ.

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