In previous postings (Intro, Part 1, Part 2), I 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 use of public information to substitute for sponsors’ studies. By definition, the 505(b)(2) application must contain information to which the [...]
Archive for May, 2011
KV’s Makena: Part 3: Use of Public Information for 505(b)(2) approvals
Published May 31st, 2011 in 505(b)(2) Process. 0 CommentsKV’s Makena Part 2: Accelerated Approval Subpart H
Published May 23rd, 2011 in 505(b)(2) Process. 0 CommentsIn a previous posting, I provided background on KV’s Makena (17a-hydroprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine the accelerated approval process. Makena was approved under 505(b)(2) as seen from the approval letter (at this writing the approval documents are not posted at [...]
KV’s Makena®: A trove of 505(b)(2) Lessons
Published May 16th, 2011 in 505(b)(2) Process, Events and How to:. 0 CommentsOn February 3, 2011 Hologic, Inc. (subsequently sold assets to KV Pharmaceuticals) received 505(b)(2) approval of Makena®, its 17α-hydroxyprogesterone caproate injection (17P) to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The subsequent announcement that the price would be set at $1500 [...]
KV’s Makena® Part 1: 505(b)(1) or 505(b)2)?
Published May 18th, 2011 in 505(b)(2) Process and News Commentary. 0 CommentsIn a previous posting, I provided background on KV’s Makena (17α-hydroprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine the choice of regulatory route. Makena was approved under 505(b)(2) as seen from the approval letter (at this writing the approval documents are not posted [...]