I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again. This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you […]
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。
The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me. Turns out that, if you are an ANDA applicant […]
When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]
While 26-30 Inches of snow fell in the Washington DC corridor, the brunt of the storm has hit the FDA with offices being closed today while the dig out continues. For those of you who had GDUFA, PDUFA goal dates, or TADs scheduled for today, you may have to wait a day or two more […]
The Office of Generic Drugs (OGD) issued MaPP 5200.7 (here) today that addresses the need for filing review for certain amendments and supplements to ANDAs. We all know that an Original ANDA must go through the filing review to determine if the ANDA is substantially complete to permit a substantive scientific review. But did you know […]
Last Friday, FDA published a Notice in the Federal Register (here) relative to staying a portion of its September 2013 Guidance Document titled Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND. The Agency indicated that, based on comment received on various sections of the final Guidance, they […]
To Compound or Not to Compound? That is the Question! FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use […]
The new GDUFA fees for 2016 were published today in the Federal Register (here) and there were some real surprises. For instance, the ANDA fee (that we thought was going to decrease given the fact that 2014 saw a record 1465 ANDAs submitted) soared and apparently FDA is justifying that the fee increase is due […]
In what was a long-anticipated action, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) announced that Dr. Kathleen “Cook” Uhl will take over the reigns of the Office of Generic Drugs (OGD) on a permanent basis.
