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FDA Warns Novartis About Manufacturing Plant

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The FDA sent a warning letter on August 12 to the drugmaker’s Sandoz generic unit about a failure to properly validate the manufacturing process for a copycat version of AstraZeneca’s Toprol XL, a blood pressure medication, which it makes a North Carolina plant.
“We question the continued distribution of this product until better process controls are [...]

Sunday, August 24th, 2008 at 12:00 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.