FDA approves expanded label for Teva's Azilect

JERUSALEM — Teva on Monday announced that the Food and Drug Administration approved an expanded label for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa to now include dopamine agonists. The approval reflects that Azilect can be used alone or with other Parkinson's disease medications.

"The FDA approval of the expanded label for Azilect will be a welcome addition in the treatment of PD," said Michael Hayden, M.D., Ph.D., president of global research and development and chief scientific officer at Teva Pharmaceutical Industries. "Teva continues its commitment to those living with PD and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs."

The FDA's approval was supported by data from the ANDANTE study (add on to dopamine agonists in the treatment of Parkinson's disease), which demonstrated that Azilect imoproved total Unified Parkinson's Disease Rating Scale scores.


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