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Monday
Teva >Press Release: Teva Announces Health Canada Approves Azilect® (Rasagiline) For Parkinson's Disease
Approved in Canada as Monotherapy in Early PD and as an Adjunct to Levodopa in Moderate-to-Advanced Disease
Jerusalem, Israel, August 21, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that AZILECT® (rasagiline tablets), the first once daily oral treatment for Parkinson's disease (PD) has just been approved by Health Canada. The drug is approved for use as initial monotherapy in early Parkinson's disease and as adjunct therapy to levodopa in moderate to advanced disease. AZILECT® is expected to become available in Canada this September.
Approval for AZILECT® was based on data from three large, multicenter, multinational, double-blind, randomized, placebo-controlled clinical studies. These studies in over 1,500 patients demonstrated that AZILECT® given once daily was effective, and well-tolerated, given as initial monotherapy in the early stages of Parkinson's disease or when added to levodopa and other therapies in more advanced stages of the disease.
"This is a key milestone for our company, but, more importantly, a significant new treatment option for the more than 100,000 Parkinson's disease patients and their families in Canada," said Jon Congleton, General Manager of Teva Neuroscience Canada. "The approval of AZILECT® is another demonstration of Teva's continuing commitment to helping people cope with neurological diseases."
The development of AZILECT® is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Teva and H. Lundbeck A/S.
To date, AZILECT®, has been made available in 19 countries most recently the United States in July.
Approved in Canada as Monotherapy in Early PD and as an Adjunct to Levodopa in Moderate-to-Advanced Disease
Jerusalem, Israel, August 21, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that AZILECT® (rasagiline tablets), the first once daily oral treatment for Parkinson's disease (PD) has just been approved by Health Canada. The drug is approved for use as initial monotherapy in early Parkinson's disease and as adjunct therapy to levodopa in moderate to advanced disease. AZILECT® is expected to become available in Canada this September.
Approval for AZILECT® was based on data from three large, multicenter, multinational, double-blind, randomized, placebo-controlled clinical studies. These studies in over 1,500 patients demonstrated that AZILECT® given once daily was effective, and well-tolerated, given as initial monotherapy in the early stages of Parkinson's disease or when added to levodopa and other therapies in more advanced stages of the disease.
"This is a key milestone for our company, but, more importantly, a significant new treatment option for the more than 100,000 Parkinson's disease patients and their families in Canada," said Jon Congleton, General Manager of Teva Neuroscience Canada. "The approval of AZILECT® is another demonstration of Teva's continuing commitment to helping people cope with neurological diseases."
The development of AZILECT® is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Teva and H. Lundbeck A/S.
To date, AZILECT®, has been made available in 19 countries most recently the United States in July.