FDA approves a new generic valsartan

FDA批准新的仿制缬沙坦

Agency prioritizing review of ARB applications to help mitigate shortage of valsartan

FDA优先审评ARB申报以帮助缓解缬沙坦短缺

March 12, 2019

Today, the U.S. Food and Drug Administration approved anew generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.

FDA今天批准了一个新的DIOVAN仿制药(缬沙坦)。缬沙坦是ARB用于治疗高血压和尽力衰竭。FDA优先审评此药品申报以帮助缓解此关键药品最近由于几个生产商的仿制缬沙坦药品因发现一些批次缬沙坦和其它ARB药品中含有亚硝胺杂质导致多起召回引发的短缺情况。

“We know that the ongoing recalls to prevent certain lotsof valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” said FDA Commissioner Scott Gottlieb, M.D. “So to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products. When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products. We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products. We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage.”

“我们知道为防止一些批次含有不可接受水平杂质的缬沙坦被患者使用而发起持续的召回导致了这些重要药品的短缺,”FDA局长说,“因此为了解决由于这些短缺引发的公众健康问题,我们现在已对这些缬沙坦药品的仿制申报进行了优先审评。在面临药品短缺时,FDA采用了大量手段来帮助缓解短缺对患者的影响。作为这些工作的一部分,我们看到可以优先对短缺药品的在审仿制申报进行审评,同时我们承诺会采取措施防止在目前和将来药品生产工艺中形成这些杂质。我们将继续与生产商合作,让更多不含亚硝胺杂质的缬沙坦类药品和属于同类ARB的药品得到批准,继续解决持续的短缺状况”。

Since last summer, the FDA has conducted a major investigation to address the presence of nitrosamine impurities in certain generic ARB products. The FDA has worked with companies to take swift action to remove any products with unacceptable impurities from the U.S. market, and continues evaluating other ARBs to ensure they are free of impurities. FDA scientists have made important strides in understanding how these impurities may form during the manufacturing process and the agency is working with international drug regulatory agencies to make new testing methods available. The FDA has also engaged drug manufacturers and helped facilitate manufacturing process changes to ensure ARBs are free of detectable levels of nitrosamine impurities. Now that this risk has been identified, the agency is implementing new requirements to guard against the development of these impurities in drugs.

自去年夏天以来,FDA已对一些仿制ARB药品中出现亚硝胺杂质的事件进行了大量调查。FDA与公司共同努力,采取果断措施将所有含有不可接受杂质的药品从美国市场清出,并继续对ARB进行评估以确保其不含有这些杂质。FDA的科学家们在了解这些杂质在生产工艺中如何形成方面已获得极大进展,FDA还与国际药品监管机构合作开发出了新的检验方法。FDA亦与药品生产商合作,帮助他们进行生产工艺变更以确保ARB不含有可检出水平的亚硝胺杂质。现在该风险已得到识别,FDA正在实施新的要求来防止药品中出现这些杂质。

In cases of severe shortages of critical medications, including the ongoing shortage of valsartan and now losartan products, the FDA plays an important role in mitigating these challenges. For example, the FDA can expedite review of a new or generic drug application that, if approved, may help mitigate or prevent such a shortage and to do so, prioritizes these inspections and reviews. The agency is also working closely with manufacturers to see if they can produce additional supplies of these medicines. FDA scientists are using the information learned from its investigation to evaluate all ARBs currently on the market and will also apply this information when assessing future applications to ensure that the manufacturing process can’t form these impurities.

如果临床用药出现严重短缺,包括缬沙坦的持续短缺以及现在是氯沙坦药品,FDA会在缓和这些挑战方面起到重要作用。例如,FDA可加速新的或仿制药品申报的审评,如果获得批准,则可帮助缓和或防止此类药品短缺,为此,需要优先安排这些现场检查和审评工作。FDA亦与生产商紧密合作,查看他们是否可以为这些药品提供更多供应数量。FDA的科学家们正在使用从这些调查中获得的信息来评估当前在市场上的所有ARB,并且会利用这些信息来评估未来的申报,以确保生产工艺不会形成这些杂质。

For this approval, the FDA evaluated the company’s manufacturing processes and also made sure they used appropriate testing methods to demonstrate that the valsartan product approved today does not contain NDMA or NDEA. The FDA’s assessment of the manufacturing processes for the product determined that there is no known risk for the formation of other nitrosamine impurities.

在此次批准中,FDA评估了公司的生产工艺,确保他们使用了适当的检验方法来证明今天批准的缬沙坦药品中不含有NDMA或NDEA。FDA的对该药品生产工艺的审评认为没有形成其它亚硝胺杂质的已知风险。

The FDA continues to investigate ARB medicines that contain nitrosamine impurities and that do not meet the agency’s quality standards. The agency will continue to the lists on FDA’s website of recalled valsartan,losartan and irbesartan products as more information becomes available from ongoing testing. If patients take an ARB drug product, they should check the lists periodically, as information may change. Not all ARB medicines have been recalled.

FDA将继续调查含有亚硝胺杂质且不符合FDA质量标准的ARB药品。FDA会在获得更多持续检验信息时继续更新FDA官网上召回缬沙坦、氯水平坦和厄贝沙坦药品清单。如果患者正在服用ARB药品,他们应定期检查这些清单,因为信息可能会有所变化。召回并不是针对所有ARB药品。

According to the National Heart, Lung, and Blood Institute, high blood pressure is a common disease in which blood flows through blood vessels, or arteries, at higher than normal pressures. Heart failure is a condition in which the heart cant pump enough blood to meet the bodys needs.

根据国家心肺血液研究所的说法,高血压是一种常见疾病,患者动静脉血流会高于常压。心力衰竭则是心脏不能泵入足够血液满足身体需求的情况。

The most common side effects associated with valsartanare dizziness, hypotension, high levels of potassium in the blood (hyperkalemia) and increased blood creatinine.

最常见的缬沙坦副反应是晕眩、血压过低、血钾高(高钾)和血肌酐增加。

Today’s approval of the new generic of Diovan was granted to Alkem Laboratories Limited.

今天批准的新仿制药DIOVAN属于Alkem实验室有限公司。

The FDA, an agency within the U.S. Department of Healthand Human Services, protects the public health by assuring the safety,effectiveness, and security of human and veterinary drugs, vaccines and otherbiological products for human use, and medical devices. The agency also isresponsible for the safety and security of our nation’s food supply, cosmetics,dietary supplements, products that give off electronic radiation, and forregulating tobacco products.