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FDA reviewer: Teva's studies fail to support expanded Parkinson's use for Azilect

 
• By Donna Young

There is no demonstrated benefit of Teva's Azilect (rasagiline) for slowing the rate of progression of Parkinson's disease, a US FDA drug reviewer said, insisting that the company's data were "not robust" enough to support such a claim.

There is no demonstrated benefit of Teva's Azilect (rasagiline) for slowing the rate of progression of Parkinson's disease, a US FDA drug reviewer said, insisting that the company's data were "not robust" enough to support such a claim.

While Dr Leonard Kapcala, a clinical reviewer in the FDA's Division of Neurology Products, said he was deferring his final...

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