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Accutane Update Is First Time For Wholesaler Instructions In A Product Label

Executive Summary

A recently approved risk management program to prevent pregnancies in patients taking isotretinoin (Roche's Accutane and generics) includes the unprecedented addition of wholesaler-focused instructions to prescription drug labeling

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FDA revises iPLEDGE dates

FDA revises implementation dates for iPLEDGE, the risk management program for Roche's Accutane and isotretinoin generics, to allow more time for registration and activation, agency announces Oct. 28. Wholesalers and pharmacies must now be registered/activated on iPLEDGE by Dec. 30, rather than Nov. 1. The patient registration start date also has been pushed back from Nov. 1 to Dec. 30. After March 1, only prescribers activated in iPLEDGE are permitted to prescribe isotretinoin to patients who are registered in the risk management program. FDA adopted the program in August as part of a restricted distribution initiative aimed at preventing pregnancies in patients taking the acne medication (1"The Pink Sheet" Aug. 22, 2005, p. 12)...

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