Article: Hoffman-La Roche to propose changes in Accutane. (recalcitrant cystic acne drug)

HOFFMAN-LA ROCHE TO PROPOSE CHANGES IN ACCUTANE

NUTLEY, N.J., April 22 /PRNewswire/ -- Hoffmann-La Roche said today that the company will propose far-reaching changes concerning its prescription drug, Accutane (isotretinoin/Roche), used for severe recalcitrant cystic acne, to prevent its use during pregnancy. As Roche has communicated since the product was first introduced in 1982, "Accutane must not be used by females who are pregnant or who intend to become pregnant while undergoing treatment."

The company said the proposed changes will be discussed next Tuesday, April 26, at a meeting with the FDA's independent Dermatologic Drugs Advisory ...

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