Accutane risk management program
Executive Summary
As of April 10, only Accutane (isotretinoin) prescriptions with "qualification stickers" will be dispensed. The stickers are intended to certify that the physician has followed the pregnancy prevention steps required in revised Accutane labeling. The updated pregnancy prevention program is being phased in over three months (1"The Pink Sheet" Nov. 5, 2001, p. 3). Accutane is poised to lose its patent exclusivity on Feb. 7...
As of April 10, only Accutane (isotretinoin) prescriptions with "qualification stickers" will be dispensed. The stickers are intended to certify that the physician has followed the pregnancy prevention steps required in revised Accutane labeling. The updated pregnancy prevention program is being phased in over three months (1 (Also see "Roche Accutane Prescriber Registry Added To Pregnancy Prevention Program" - Pink Sheet, 5 Nov, 2001.), p. 3). Accutane is poised to lose its patent exclusivity on Feb. 7.... |