FDA expands indication of Azilect for Parkinson's Disease - Teva Pharma
The FDA has expanded the indication for Azilect (rasagiline tablets), from Teva Pharma, from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs). The new indication reflects that Azilect can be used alone or in combination with other Parkinson�s disease (PD) medications.
The approval of the expanded label is based on a supplemental new drug application submitted by Teva, supported by data from the ANDANTE study which demonstrated Azilect provides a clinical benefit by significantly improving total Unified Parkinson�s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.
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