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Generic Accutane risk management

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Executive Summary

FDA is still considering risk management requirements for generic versions of Roche's Accutane (isotretinoin), the agency says in an Aug. 12 response to a Roche citizen petition. "FDA has been unable to reach a decision on your petition because it raises significant issues requiring extensive review and analysis," the agency said. Mylan's isotretinoin ANDA has been held up by discussions on risk management, but the company told analysts July 25 that Mylan has "addressed all outstanding issues" with FDA and looks "forward to an approval" (1"The Pink Sheet" August 5, In Brief)...

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