What a year for 505(b)(2) drug development! In 2011 FDA approved 44 505(b)(2) NDA submissions. Various authors have reported that FDA approved 34 or 35 drugs in 2011 (505(b)(1) NDA + BLA). I had speculated a couple of years ago that perhaps 80% of new drugs approved in 2012 would be 505(b)(2)’s, based on botha [...]
Archive for the '505(b)(2) Process' Category
2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals
Published January 9th, 2012 in 505(b)(2) Process and Events. 0 CommentsRole 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 [...]
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 [...]
KV’s Makena: Part 3: Use of Public Information for 505(b)(2) approvals
Published May 31st, 2011 in 505(b)(2) Process. 0 CommentsIn 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 [...]
KV’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 [...]
Mitosol – an Orphan & 505(b)(2) without clinical studies
Published February 7th, 2011 in 505(b)(2) Process and News Commentary. 0 CommentsMobius Therapeutics announced that it has received orphan drug status for Mitosol to prevent the recurrence of pterygium after surgical excision. The active ingredient, mitomycin has been used without FDA approval for eye surgeries since the mid 1960′s. Due to its long history of use, the FDA did not require that Mobius conduct clinical trials. [...]
Pharmacokinetic (PK) Modeling & Steady-State Simulations: Strategic Use in a 505(b)(2) Drug Development Program
Published December 13th, 2010 in 505(b)(2) Process, Formulation Issues and How to:. 0 CommentsSponsors and their investors continue to seek cost efficient ways to meet their financial milestones. Modeling can be used as a cost effective way to estimate the effect of changing an oral product from immediate release to extended release. Modeling avoids the cost of making multiple formulations and performing several multi-arm pharmacokinetic studies. The following [...]
Nuedexta® – Smart Pharmacology to Treat a Unique Disorder
Published December 11th, 2010 in 505(b)(2) Process and Formulation Issues. 0 CommentsThe FDA has approved NuedextaÃ’ (Avanir Pharmaceuticals Inc.), a drug that curbs involuntary and uncontrolled crying and laughing episodes (known as pseudobulbar affect (PBA)) that are experienced by patients with some neurological disorders. Nuedexta is the first drug to be approved to treat patients with these symptoms. Nuedexta is a combination product containing dextromethorphan hydrobromide [...]
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 [...]