August 12, 2005

US FDA unveils tighter restrictions on acne drug

WASHINGTON (Reuters) - 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.