Comments for Drug Kennel

Comment on REMS or RiskMAP or what? by Roche’s Actemra Approved For RA After Year’s Delay at Drug Kennel

Roche’s Actemra Approved For RA After Year’s Delay at Drug Kennel — Thu, 11 Feb 2010 13:30:32 +0000

[...] with additional information. Whether the need for a REMS should have been anticipated is unclear. For more about REMS, see here. However, much of the additional information requested could reasonably be expected to have been [...]

Comment on 2009 Activity by 2009 505(b)(2) Approvals at Drug Kennel

2009 505(b)(2) Approvals at Drug Kennel — Mon, 25 Jan 2010 17:44:24 +0000

[...] track approvals on this blog as they occur (click here to see my entire list of approvals* and a link to the FDA approval letters). Approvals that have [...]

Comment on Fenofibrate (TriCor) active metabolite approved by 2009 505(b)(2) Approvals at Drug Kennel

2009 505(b)(2) Approvals at Drug Kennel — Mon, 11 Jan 2010 11:31:12 +0000

[...] fenofibrate (TriCor) making changes to maintain their market monopoly – they got fenofibric acid approved. Separately, Abbott settled with Teva over generic issues (see this opinion piece for further [...]

Comment on 505(b)(2) Submissions: No RLD by Reference Listed Drugs (RLDs)—Can more than one be used? at Drug Kennel

Reference Listed Drugs (RLDs)—Can more than one be used? at Drug Kennel — Fri, 30 Oct 2009 12:10:19 +0000

[...] we considered the case of a 505(b)(2) NDA without an RLD. So let’s ask if a 505(b)(2) NDA have more [...]

Comment on FDA Reaffirms 5-year Exclusivity for a Pro-drug by Did FDA make a mistake? Prodrug Emend exclusivity reconsidered at Drug Kennel

Did FDA make a mistake? Prodrug Emend exclusivity reconsidered at Drug Kennel — Tue, 27 Oct 2009 12:18:00 +0000

[...] September 2007 « FDA Reaffirms 5-year Exclusivity for a Pro-drug [...]

Comment on MAP Pharmaceutials 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals by AstraZeneca ends collaboration with MAP Pharmaceuticals at Drug Kennel

AstraZeneca ends collaboration with MAP Pharmaceuticals at Drug Kennel — Fri, 10 Jul 2009 13:03:04 +0000

[...] for MAP, its other product candidate appears to be on track. We recently commented on the successful completion of Phase 3 for its orally inhaled [...]

Comment on 505(b)(2) Audioconference January 28, 2008 by admin

admin — Tue, 29 Jan 2008 18:10:59 +0000

It is rare that you can file a 505(b)(2) with a product that has a clinically significantly higher exposure than the RLD. This would imply that the current RLD is less than effective. In this case you cannot reply on the RLD’s determination of safety and effectiveness and will have to supply all information yourself - this could end up as a 505(b)(1).
A DESI product is a product that was on the market prior to 1962 that lacks data to support efficacy.
Ken

Comment on 505(b)(2) Audioconference January 28, 2008 by Geuntae Kim

Geuntae Kim — Mon, 28 Jan 2008 22:00:57 +0000

Hello, Mr. Ken Phelps
Thank you for your kind presentation.
I have two questions.
When the exposure of metabolite or prodrug in the application of 505b2 is higher than that of RLD, do we prepare all the preclinical data including the toxcity data in animals?

What is the DESI Product?
I will wat your reply. Thank you again

Sincerely yours,
Geun Tae Kim
LG Life Sciences

Comment on 505(b)(2) of Withdrawn Product by Mike

Mike — Mon, 28 Jan 2008 20:40:11 +0000

You mentioned in your webinar that there are cases of 505(b)(2) applications that can be submitted with no RLD and it was a discussion on your blog. I tried to find it but was unsuccessful. Can you provide some of those examples, specifically in reference to drugs that are approved in other countries such as the EU, can a 505(b)(2) be submitted or is it the 505(b)(1) route that needs to be followed.