QDIS Blog

Seems Representative Henry Waxman (D, CA) wants to hear from the following companies about the following drugs for the following reasons:

Lilly: Zyprexa (bipolar). Inappropriate promotion for off-label use
AstraZeneca: Seroquel (schizophrenia). Inappropriate marketing
Boston Scientific: drug coated stents. Safety and off-label use
Cordis: drug coated stents. Safety and off-label use
Cephalon: Actiq (narcotic lollipop) and Fentora (narcotic lozenge). Inappropriate marketing

PharmaLive: Rep. Waxman Requests Research and Marketing Information from Pharmaceutical and Medical Device Companies :

Here are the letters that were sent.

WaxmanLilly.pdf
WaxmanAZ.pdf
WaxmanBoston.pdf
WaxmanCordis.pdf
WaxmanCephalon.pdf

The longest letter went to Cephalon over their narcotic products . All the letters are asking for a long list of items to be provided covering clinical trials, audits, presentations, training material, communication to healthcare providers and much more. It will be interesting to watch and see which cooperate and which may refuse to turn over the requested documents. For Cephalon and Actiq it is for data from 1997 to the present; almost 10 years of data.

Technorati Tags: Actiq, AstraZeneca, Boston Scientific, Cephalon, Cordis, Eli Lilly, Fentora, drug coated stents, Seroquel, Waxman, Zyprexa

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Lilly last week withdrew its application with the European Medicines Agency (EMEA) for Arxxant (ruboxistaurin)

PharmaLive: Eli Lilly Withdraws Its Marketing Authorization Application for Arxxant

The given reason was that they could not respond to the request for the additional information in the required amount of time. Lilly lost an appeal just a few days earlier than this where the FDA upheld thier decision to require additional clinical trials before it would be considered for approval. Lilly said it would take an additional 3-5 years to complete those studies.

My wife is diabetic and has already had some eye problems related to her disease and so I have been following this drug with a personal interest. It will be interesting to see what Lilly will do. Somewhere right now someone is plugging numbers into a spreadsheet to see if it is worthwhile for Lilly to make an additional investment in this drug. Since I have a personal interest in this, I certainly hope so.

Other Resources
Eli Lilly withdraws its marketing authorisation application for ARXXANT (from EMEA website)
FDA rejects Eli Lilly appeal - Pharmaceutical Business Review
Lilly’s Arxxant Hits FDA Snag - Forbes.com (from back in Aug 2006)
Approvable Letter Issued By FDA For Arxxant(R) (ruboxistaurin Mesylate) For Diabetic Retinopathy

Arxxant - Yahoo! Search Results
Arxxant - Google Search
Google Blog Search: Arxxant

Technorati Tags: Arxxant, ruboxistaurin

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