Extract form GWs web pages.
United States
Why is GW interested in the United States as a market-place?
GW seeks to address serious unmet patient needs in a number of medical conditions in countries across the world. We believe that there are many patients in the US who could benefit from access to FDA-approved, prescription cannabis-derived medicines. We therefore wish to subject our pharmaceutical product and research data to the rigorous scrutiny of the FDA regulatory process, and we are now making the first steps along that road.
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When will Sativex® be available in the US?
As we extend our development program to other countries, GW continues to strive, in accordance with each nation’s regulatory system, to achieve our goal of making cannabis-derived prescription medicines available to patients with serious unmet medical needs. Accordingly, GW intends to meet with the FDA during the second half of 2005 to discuss the specific regulatory requirements for approval of Sativex® in the US. Sativex® will be available on prescription in the US only when it has satisfied the FDA’s standards for quality, safety, and efficacy.
Can we assume that GW have had the meeting with the FDA, this is just the first step on a long road to approval.
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