Teva Opts For Azilect Tyramine Warning Rather Than Conduct "Adequate" Study
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Teva agreed to a tyramine sensitivity warning in labeling for Azilect (rasagiline) after FDA deemed the firm's studies inadequate to characterize the problem
You may also be interested in...
FDA Turns To Epidemiological Data To Resolve Azilect Melanoma Questions
FDA used an epidemiological approach to resolve concerns regarding a potentially higher risk of melanoma with Teva’s Parkinson’s disease therapy Azilect, review documents show.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011