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FDA Doesn't Green-Light Abbott Drug

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Some disappointing news for north suburban-based Abbott Labs. The drug-maker says federal regulators have not approved a form of the company’s pain-killer, Vicodin.

Controlled Release Vicodin, or “Vicodin C-R,” would allow patients to take fewer pills each day to relieve their pain. But it’s not hitting the shelves just yet.

The Food and Drug Administration sent Abbott a “Complete Response Letter.” According to the FDA website, that means the agency has fully reviewed the drug’s application, and “cannot approve [it] in its present form.”
Abbott had predicted approval of Vicodin CR this quarter. In a statement Monday, the company said it will discuss the matter with the FDA.

I’m Sam Hudzik, Chicago Public Radio.

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