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Mylan generic Accutane launch

Executive Summary

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)...

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