Skip to Content

Azilect Approval History

  • FDA approved: Yes (First approved May 16th, 2006)
  • Brand name: Azilect
  • Generic name: rasagiline mesylate
  • Dosage form: Tablets
  • Previous name: Agilect
  • Company: Teva Pharmaceutical Industries Ltd.
  • Treatment for: Parkinson's Disease

Azilect (rasagiline) is a monoamine oxidase -B inhibitor administered once-daily as initial monotherapy in early Parkinson's Disease (PD) and as adjunct therapy to levodopa in moderate-to-advanced disease.

Development History and FDA Approval Process for Azilect

Dec 14, 2009Approval FDA Approves Newly Revised Prescribing Information for Azilect Reducing Medication and Food Restrictions
May  8, 2005Teva Receives Follow-up Approvable Letter from FDA Regarding Agilect
Jul  5, 2004Teva Receives Approvable Letter for Agilect (rasagiline)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.