Mylan Generic Accutane Forecast Assumes May/June Launch
Executive Summary
Mylan is forecasting the launch of its generic version of Roche's acne therapy Accutane late in the April-June quarter
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Mylan Generic Isotretinoin Risk Program To Use BU’s Slone Epidemiology
Mylan generic isotretinoin risk management will be conducted at the Slone Epidemiology Unit of Boston University School of Public Health, the same institution Roche has been using for its risk management program for Accutane
Mylan Generic Isotretinoin Risk Program To Use BU’s Slone Epidemiology
Mylan generic isotretinoin risk management will be conducted at the Slone Epidemiology Unit of Boston University School of Public Health, the same institution Roche has been using for its risk management program for Accutane
Mylan generic Accutane launch
Mylan has "addressed all outstanding issues" with FDA over a generic isotretinoin launch and is "prepared to comply with all risk management program requirements before us," Senior VP Jim Mauzey says. "Our sales representatives are trained on the product, and our wholesalers and retail customer base has been contacted and presented with our program for introduction. We look forward to an approval." The ANDA has been held up by discussions regarding appropriate risk management for Accutane (1"The Pink Sheet" March 11, p. 16)...