US FDA unveils tighter restrictions on acne drug

Patients and doctors must register with manufacturers before using or prescribing Roche Holding AG’s acne drug Accutane or its generic versions, U.S. regulators said on Friday.

The requirement is part of a plan to strengthen safeguards meant to keep pregnant women from taking Accutane, the Food and Drug Administration said in a statement. The drug can cause birth defects.

The FDA also said it approved changes to existing warnings “so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and Depression” before and after prescribing Accutane.

The FDA had announced plans for tighter controls on Accutane in November 2004.

Accutane also is known by the generic name isotretinoin. Mylan Laboratories Inc., Ranbaxy Laboratories Ltd. and Barr Pharmaceuticals sell generic versions of the drug.

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