Women's Health Weekly
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Drug Safety
U.S. FDA requests opioid drug label changes from pharmaceutical company
August 18th, 2005
Ligand Pharmaceuticals Incorporated (LGNDE) announced receipt of a letter from the U.S. Food and Drug Administration (FDA) requesting that the company make changes to the label of its sustained-release opioid product, Avinza once-a-day morphine sulfate extended-release capsules. The FDA letter said, "In vitro observations indicate that the extended-release characteristics of Avinza are compromised in the presence of alcohol. Until the clinical implications of these data are fully assessed, we request that changes be made to the package insert," with the intent to provide adequate information for the safe and effective use of the drug. The company has also been asked by...
Source: Women's Health Weekly (2005-08-18)
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