翻譯：JULIA 來源：Julia法規翻譯
FDA approves a new generic valsartan
FDA批准新的仿製纈沙坦
Agency prioritizing review of ARB applications to help mitigate shortage of valsartan
FDA優先審評ARB申報以幫助緩解纈沙坦短缺
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今天批准了一個新的DIOVAN仿製藥（纈沙坦）。纈沙坦是ARB用於治療高血壓和盡力衰竭。FDA優先審評此藥品申報以幫助緩解此關鍵藥品最近由於幾個生產商的仿製纈沙坦藥品因發現一些批次纈沙坦和其它ARB藥品中含有亞硝胺雜質導致多起召回引發的短缺情況。
「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.」
「我們知道為防止一些批次含有不可接受水平雜質的纈沙坦被患者使用而發起持續的召回導致了這些重要藥品的短缺，」FDA局長說，「因此為了解決由於這些短缺引發的公眾健康問題，我們現在已對這些纈沙坦藥品的仿製申報進行了優先審評。在面臨藥品短缺時，FDA採用了大量手段來幫助緩解短缺對患者的影響。作為這些工作的一部分，我們看到可以優先對短缺藥品的在審仿製申報進行審評，同時我們承諾會採取措施防止在目前和將來藥品生產工藝中形成這些雜質。我們將繼續與生產商合作，讓更多不含亞硝胺雜質的纈沙坦類藥品和屬於同類ARB的藥品得到批准，繼續解決持續的短缺狀況」。
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.
自去年夏天以來，FDA已對一些仿製ARB藥品中出現亞硝胺雜質的事件進行了大量調查。FDA與公司共同努力，採取果斷措施將所有含有不可接受雜質的藥品從美國市場清出，並繼續對ARB進行評估以確保其不含有這些雜質。FDA的科學家們在了解這些雜質在生產工藝中如何形成方面已獲得極大進展，FDA還與國際藥品監管機構合作開發出了新的檢驗方法。FDA亦與藥品生產商合作，幫助他們進行生產工藝變更以確保ARB不含有可檢出水平的亞硝胺雜質。現在該風險已得到識別，FDA正在實施新的要求來防止藥品中出現這些雜質。
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.
如果臨床用藥出現嚴重短缺，包括纈沙坦的持續短缺以及現在是氯沙坦藥品，FDA會在緩和這些挑戰方面起到重要作用。例如，FDA可加速新的或仿製藥品申報的審評，如果獲得批准，則可幫助緩和或防止此類藥品短缺，為此，需要優先安排這些現場檢查和審評工作。FDA亦與生產商緊密合作，查看他們是否可以為這些藥品提供更多供應數量。FDA的科學家們正在使用從這些調查中獲得的信息來評估當前在市場上的所有ARB，並且會利用這些信息來評估未來的申報，以確保生產工藝不會形成這些雜質。
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評估了公司的生產工藝，確保他們使用了適當的檢驗方法來證明今天批准的纈沙坦藥品中不含有NDMA或NDEA。FDA的對該藥品生產工藝的審評認為沒有形成其它亞硝胺雜質的已知風險。
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 update 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將繼續調查含有亞硝胺雜質且不符合FDA質量標準的ARB藥品。FDA會在獲得更多持續檢驗信息時繼續更新FDA官網上召回纈沙坦、氯水平坦和厄貝沙坦藥品清單。如果患者正在服用ARB藥品，他們應定期檢查這些清單，因為信息可能會有所變化。召回並不是針對所有ARB藥品。
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 can't pump enough blood to meet the body's needs.
根據國家心肺血液研究所的說法，高血壓是一種常見疾病，患者動靜脈血流會高於常壓。心力衰竭則是心臟不能泵入足夠血液滿足身體需求的情況。
The most common side effects associated with valsartanare dizziness, hypotension, high levels of potassium in the blood (hyperkalemia) and increased blood creatinine.
最常見的纈沙坦副反應是暈眩、血壓過低、血鉀高（高鉀）和血肌酐增加。
Today’s approval of the new generic of Diovan was granted to Alkem Laboratories Limited.
今天批准的新仿製藥DIOVAN屬於Alkem實驗室有限公司。
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.