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news.Map Pharmaceuticals has announced that the US Food and Drug Administration (FDA) asked the company to address manufacturing issues related to its migraine medication, Levadex.
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The FDA did not complete the review of Levadex’s new drug application, because of chemistry, manufacturing and controls issues observed during an inspection of the third-party manufacturer, the company said.
The FDA did not point out any clinical safety or efficacy issues with Levadex or asked for any more clinical studies before it approves the drug.
The company is planning to request a meeting with the agency to discuss the issues it raised.