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Azilect 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 History and FDA Approval Process for Azilect

DateArticle
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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