In previous postings (Intro, Part 1, Part 2, Part 3), I have provided background on KV’s Makena (17a-hydroxyprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine the difference between statistical and clinical significance. Please note that this is not meant as a rigorous statistics [...]
Archive for June, 2011
KV’s Makena Part 4: Statistical versus Clinical Significance
Published June 14th, 2011 in Uncategorized. 0 CommentsYesterday (08Jun11) The Wall Street Journal reported (subscription may be required) that Pfizer will cut an additional $1 Billion – mostly in administrative costs. These cuts come after cuts to sales and R&D. What’s driving all of these cuts is two-fold: loss of sales of their products to generics and failure to obtain approval for [...]
Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products
Published June 8th, 2011 in 505(b)(2) Process and How to:. 0 CommentsWe believe that the 505(b)(2) drug development pathway is best used when we can improve the safety and/or efficacy of an existing drug product. We see many opportunities to improve clinical effectiveness, but before trying to prove this in a clinical setting – which is time-consuming and costly, we try to examine the hypothesis using other [...]
Why generic companies might like 505(b)(2)
Published June 2nd, 2011 in ANDA's and News Commentary. 0 CommentsHow would you like to spend a couple of hundred thousands of dollars (or equivalent local currency) and countless months getting FDA approval and patent expiration and then face 14 competitors? What’s the ROI for that? June 1, 2011 Donepezil Hydrochloride Tablets, Matrix Laboratories Ltd., Approval Donepezil Hydrochloride Tablets, Cipla Ltd., Approval Donepezil Hydrochloride Tablets, Wockhardt [...]
Ophthalmics: 21 CFR 314 94(a)(9)(iv) no longer applies
Published June 2nd, 2011 in 505(b)(2) Process, ANDA's and Formulation Issues. 0 CommentsWho would have guessed that 21 CFR 314.94(a)(9)(iv) no longer applies to ophthalmics? You wouldn’t generally have expected it to just be cancelled – normally FDA must go through notice and comment, but apparently the FDA can make a regulation disappear by decree. 21 CFR 314(a)(9)(iv) states: (iv)Inactive ingredient changes permitted in drug products intended [...]
Whew! Supreme Court rules generic labels must track RLD
Published June 24th, 2011 in News Commentary. 0 CommentsA lot of generic companies are breathing easier today. As we discussed in this blog before, two district courts ruled that generic companies must comply with state laws and add warnings to the label even if it differs from that of the brand product (the Reference Listed Drug – RLD). The cases went to the [...]