On November 21, 2016 we issued an important alert (here) relative to the FDA activities regarding the proposed GDUFA II Program Fees and the responsibility of industry to review the list and provide feedback to FDA relative to its accuracy and whether there was an affiliate relationship among entities listed. This so-called “cleanup” activity […]
We are pleased to announce that Daniel Barreto will join Lachman Consultants as Vice President, Compliance Practice, effective December 12, 2016. Mr. Barreto comes to Lachman Consultants with nearly four decades of extensive international experience in the pharmaceutical industry developing and implementing quality strategies and programs to support a continuous state of compliance and consistent […]
In a November 28, 2016 FDA response denying two Citizen Petitions (here) asking that the Agency determine that the older discontinued formulation of Protonix IV was not withdrawn for safety of efficacy reasons, the FDA said it was and provided a 7-page explanation of its reasons. They explained that when Protonix IV was first approved, […]
近年来FDA完成了多少处方药到非处方药的转换？通过我们掌握的2001年至2016年的数据来看，FDA报告的数量为38个 – 虽然其中有些不是真正的处方药到非处方药转换（将在下面予以解释）。 在过去5年中，只有6次药品完成转换，但在报告前5年（2001-2005年）完成了14次转换。最高的转换次数是5次，共4年（2002年，2006年，2007年和2011年）。到目前为止，最常见的处方药列为成药的是咳嗽/感冒疾病类的药物，在38个产品中占的16个。还有那些在我喜欢称为“类别之外的”（我从来没有想到会被批准为非处方药的产品）： 氟替卡松Sensimist过敏缓解剂（氟替卡松糠酸酯）（FDA 在2016年唯一一个被转换为非处方药的处方药） 雷诺考特过敏喷雾（布地奈德）（FDA 在2015年唯一一个被转换为非处方药的处方药） 2014年 丙酸氟替卡松缓解剂 2013年 奥昔布宁膀胱过度活动症 2007年 奥利司他减肥药 2006年计划B 如上所述，38个药品中的一些产品不是真正意义上的处方药转换，如真实转换所表示的，产品首先作为处方产品销售，然后转为非处方药状态。 FDA确定了3种此类产品（Mucinex所有含有愈创甘油醚的产品）。 FDA注意到，这些新药申请并非真正的转换， 因为这些产品在被批准为非处方药上市之前，就已作为处方药品上市却无批准的NDA。 Prevacid 长效制剂（24小时），Zegrid 非处方药，Alli和Prilosec 非处方药，上述4种产品被FDA指出“这些NDA不是真正的转换，因为在被批准成为上市非处方药之前，使条件并非按照NDA批准作为处方药产品上市。”尽管如此，FDA将这些产品作为非处方药转换在其表中。在接下来的几年中，观察处方药转换为非处方药的数目是否有所增加是很有趣的，因为一些产品已经发出一个潜在走势的信号。 点击链接可查看每年完整的转换列表。
Ever wonder how many Rx-OTC switches FDA has made over the years? Well, now we have that data from 2001 through 2016 and that number is reported at 38 by the FDA – albeit, there are a few in that total that are not true Rx-to-OTC switches (we will explain that later). Over the last […]
The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing, processing, packing or holding). In addition, as […]
On Monday, the Office of Generic Drugs (OGD) updated its report on the activity of the Generic Drug Program to include additional data. As this is the report for the first month of the new fiscal year (2017), any comparative data needs to come from previous fiscal years. The October report adds Refuse-to-Receive (RTR) actions, […]
FDA has revised its bioequivalence recommendation for cyclobenzaprine hydrochloride extended-release capsules. This revision was based on a petition submitted by the current NDA holder and marketer of the product (here). In that petition, the NDA holder requested that FDA require any ANDA applicant to perform an additional bioequivalence study beside the fasting and fed in-vivo […]
Whether you are into tofurkey, real turkey, ham or whatever floats your boat, all of us at Lachman Consultants want to take a moment to wish you and yours a happy Thanksgiving. At this time of year, we all need to take stock (no pun intended) of our family and friends and realize that, while […]
In the GDUFA II negotiations, there have been some significant changes in the fee structure. For instance, no facility will pay an establishment fee until it is named in an approved application; CMOs will only pay one-third of the establishment fee when named in an approved application; the prior approval supplement fee has been eliminated; […]
