Repurposing, repositioning – by whatever name, the 505(b)(2) drug development pathway is gaining traction. I will be giving a talk entitled “505(b)(2) Product Candidate Selection-Which Old Dog to Rejuvenate” on December 10 at the Drug Repurposing Strategies meeting. The conference costs $1695 but friends of Camargo can get a $400 discount – just contact me [...]
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You are currently browsing the Drug Kennel weblog archives for the month November, 2008.
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- 2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals
- What is an Approved DESI Product?
- Stability Changes coming to ANDAs
- Don’t launch unapproved products after 9/19/2011
- AB Rated 505(b)(2)’s
- 2012 PDUFA User Fees
- Whew! Supreme Court rules generic labels must track RLD
- KV’s Makena Part 4: Statistical versus Clinical Significance
- Patent Cliff Causes Pfizer Cuts
- Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products
Medicaid paid for unapproved DESI drugs
Published November 25th, 2008 in News Commentary. 0 CommentsA minor ripple in the media, the Associated Press reviewed Medicaid records and found that since 2004, Medicaid has paid at least $200 million for unapproved drugs (perhaps $50MM per year). “Unapproved” sounds scary, right? These drugs are DESI drugs that are not normally reimbursed. $200 million pales in comparison to the amounts that Medicaid has paid. For [...]