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FDA Warns Canadian Pharmacy for Trying to Sell Unapproved Drug to Onfi Patients, Labeling Issues

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The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011.

Additionally, the FDA called attention to the fact that the clobazam offered by Mark’s is misbranded because the labeling for the drug does not have adequate directions for use.

Further, the online purchases of the Canadian drug fail to include an FDA-approved med guide, required to be dispensed with Onfi.

Labeling remains one of the most intensely scrutinized aspects in agency inspections.

But worry not. This October, an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders convene at the Third Annual Pharmaceutical Labeling Summit to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

Let their expertise help you get the FDA’s OK on your next labeling change! Mark your calendar for the Summit, taking place Oct. 16-17, 2012, in Washington, D.C.