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FDA revises iPLEDGE dates

Executive Summary

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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