FDA approves expanded label for Teva's Azilect Teva Pharmaceutical Industries announced the U.S. Food and Drug Administration has expanded the indication for AZILECT from monotherapy and adjunct to levodopa to now include adjunct to dopamine agonists. The new indication reflects that AZILECT can be used alone or in combination with other Parkinson's disease medications. The approval reinforces the growing clinical evidence demonstrating the benefit of AZILECT across all stages of PD. The FDA approval of the expanded label is based on a supplemental new drug application submitted by Teva, supported by data from the ANDANTE study. The study demonstrated AZILECT provides a clinical benefit by significantly improving total Unified Parkinson's Disease Rating Scale scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.