US FDA Unveils Tighter Restrictions On Roche Holding AG's Acne Drug
10/19/2005 5:09:08 PM
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 announced 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.