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Statins Could Still Go OTC,Despite Recent Setback

机译:尽管近期遭遇挫折,他汀类药物仍可继续上柜交易

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摘要

THOUGH THE Food and Drug Administration is likely to reject Merck & Company Inc.'s request to offer an over-the-counter version of its prescription cholesterol drug Mevacor(lovastatin)later this month,industry experts believe OTC statins will eventually make their way onto the US market.If so,they may blaze a path for the regulatory acceptance of switches in other classes of drugs as well.An FDA advisory committee last month recommended against an OTC switch for Mevacor,citing a laundry list of issues that it suggested Merck still needed to address before the drug could safely put on the market.
机译:尽管美国食品药品监督管理局很可能会拒绝本月晚些时候Merck&Company Inc.提供非处方版本的处方胆固醇药物Mevacor(lovastatin)的要求,但业内专家认为,OTC他汀类药物最终会成功进入美国市场。如果这样的话,它们也可能为其他类别的药物转换的监管接受开辟道路。FDA咨询委员会上个月建议不要对Mevacor进行OTC转换,并列举了一份建议清单默沙东仍需要解决该药物才能安全投放市场的问题。

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