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FDA questions Teva drug's impact on Parkinson's

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Old 10-13-2011, 06:39 PM #1
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Default FDA questions Teva drug's impact on Parkinson's
FDA questions Teva drug's impact on Parkinson's

AP via Yahoo! Malaysia News Thu, 13 Oct 2011 11:04 AM PDT
Studies of Teva Pharmaceuticals' drug Azilect for Parkinson's disease failed to convince federal scientists that the pill slows the progression of the disease, suggesting the government will reject the company's bid for expanded use of the drug.
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Old 10-17-2011, 04:31 PM #2
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FDA panel unanimously votes down Parkinson's drug

Boston Globe, October 17, 2011

But the FDA's panel of outside experts voted 17-0 against recommending approval for that use, saying the company's clinical study results were not convincing.
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Old 10-17-2011, 04:35 PM #3
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AZILECT® (RASAGILINE MESYLATE) FOR SLOWING CLINICAL PROGRESSION IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE3

BRIEFING DOCUMENT FOR THE PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE MEETING

MEETING DATE OCTOBER 17, 2011

pdf file document
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Old 10-17-2011, 09:50 PM #4
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They said the same thing about Mirapex, and that was bogus too..Hell of a sales pitch
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Old 10-17-2011, 11:10 PM #5
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To make it clear, the vote was against the claim that Rasagiline slows progression. The approval for symptomatic reasons is unchanged.

John
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Current meds: Stalevo(75 mg) x 5, ropinirole xl 8 mg, rasagiline 1 mg
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Old 10-18-2011, 09:20 AM #6
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Default statement from PD orgs
The six major PD orgs issued a joint statement on the issue yesterday. I put it in a new thread here:
http://neurotalk.psychcentral.com/thread159340.html
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