FDA approves label changes for Accutane and its generics

The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.

The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.

Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.

The changes are planned to go into effect on Dec. 2.

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