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Azilect FDA Approval History

FDA Approved: Yes (First approved May 16, 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 timeline 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)

Further information

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