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Orlaam (Levomethadyl Acetate Hydrochloride)

September 9, 2003

Audience: Pharmacists and drug dependency healthcare professionals

Roxane Laboratories, Inc. is discontinuing the sale and distribution of ORLAAM, a synthetic opioid agonist solution indicated for the management of opiate dependence, reserved as second-line therapy for the treatment of opiate-addicted patients who fail to show acceptable response to other adequate treatments for opiate addiction. ORLAAM was removed from the European market in March 2001 following reports of severe cardiac-related adverse events, including QT interval prolongation, Torsades de Pointes and cardiac arrest. Other first-line treatment options are available for the management of opiate dependence, including methadone and buprenorphine. Roxane extimates that the current inventory of this product will be depleted by February 2004 and encouraged healthcare providers to transfer patients to alternative treatments as soon as possible prior to the product’s unavailability.

[Sept 2, 2003 Letter - Roxane Laboratories, Inc]

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