It has been just about 11.5 years since FDA approved an OTC version of MiraLAX and the innovator withdrew the Rx-labeled NDA product from the market. Why did it take this long? Other than the fact that ANDAs approved prior to the approval of the OTC version were making significant profits, there were differences between […]
Everyone associated with generic drug submission realizes that generic companies that want to market a copy of a drug product prior to the expiration of a patent must file a patent challenge to existing patents (a so-called Paragraph IV [“PIV”] challenge). FDA updates its list of PIV submissions so other firms will know the date […]
Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has […]
即便由于元素杂质问题导致ANDA审批放缓， 2018年头两个月批准数量下降（点击这里），但首仿药 ANDA批准的数量似乎高于预期 。截至2018年3月8日，美国食品药品监督管理局（FDA）公布了10种首仿药（注：如果多名申请人在同一天获得批准，可能会出现同一种药物的多份报告）。 首仿药 批准对于行业和消费者来说似乎皆大欢喜，但果真如此吗？在大多数情况下的确如此，因为它引入了首仿药选项（其价格始终低于其仿制的原研药）。单个单仿药批准可以节省15-20％的原研药价格，并且可以为参保患者提供较低的分摊付款额。该领域的审批一旦多起来（比如说有6至10个甚至更多获批准的申请），由于竞争激烈，原研药价格可能会在很短的时间内降至90％。 听起来对消费者来说都是喜讯，但并不是所有的仿制药都能在批准后立即上市。一些公司可能要对其商业制造过程进行最终验证研究。在某些情况下，活性药物成分供应商或当前批准的生产场地会出现一些问题，需要在批准后和上市前进行整改。甚至有些申请人还会面临另一个棘手问题。 切记，FDA可以在仿制药公司向专利持有人和ANDA申请人发出通知后30个月内批准一项包含专利质询（即所谓的PIV ANDA）的ANDA，说明FDA认为专利无效的依据，要么 其产品造成侵权要么不具有可执行性。即使公司在“30个月延期”期满并在专利诉讼解决之前可以获得FDA的ANDA批准，但ANDA申请人可能并不希望在专利案得到ANDA提案人妥善解决之前投入市场。在3月14日 的 粉单市场（Pink Sheet）报道过这样的案例：“……尽管美国FDA批准了Amgen公司Sensipar（盐酸西那卡塞片）的两种仿制药品，但由于原研药钙敏感受体激动剂的介入，可能需要等待特拉华联邦地区法院提起的专利诉讼结果。” 一旦在解决专利诉讼之前获得FDA批准，仿制药公司就可以选择药品上市；然而，如果该公司在专利案中败诉，所获得的ANDA批准可能会被撤销，其申请也将回到待决状态，并且该公司可能承担三倍赔偿责任，这是“败诉公司”很可能获得的败诉结果 因此，首仿药 批准对消费者来说通常都是个喜讯；但是，即便这些药品批准的新闻被媒体报道，如果专利诉讼悬而未决或者其他问题导致公司无法立即推出其药品，则对消费者的影响可能不会来得那么快。
Despite being the co-leader and taking the number one or two spots in Warning Letters received with India for the last few years, China had made great strides in obtaining ANDA approvals. According to an article by Jin Zhang M.D., Ph.D, on PharmaExec.com (here), Chinese firms received 38 ANDA approvals in 2017 (that is 5% […]
In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.” This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA). The anticipated outcomes of […]
Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ). The testimony addresses the following major points. It is critical that we combat the […]
Since January 2018, the number of ANDA approvals has slowed dramatically. In the first three months of FY 2018 (beginning in October 2017), ANDA approvals were averaging 83 a month. The monthly average for January and February was 28.5. We know that the slowdown in approvals was due in large part to the change in […]
Today, the FDA released a new report titled Activities Report of the Generic Drugs Program (FY 2018) – GDUFA II Quarterly Performance (here) which has some new figures we have not seen in any form before. The new information includes mean and median approval time by cohort action for both original and tentative approvals […]
Even though the slowdown in ANDA approvals, attributable to the issues of elemental impurities, has dampened the first two month of 2018 (here), the number of first-time generic ANDA approvals seems to be higher than would be expected. FDA reported 10 first-time generics (note that there may be multiple reports for the same drug if […]
