nebido aveed fda split vote

[gatchaman]

So, i've been following the FDA public docs on the Aveed FDA approval. However, due to my newbiness, I am unable to post links, so here is my very very short summary with google search terms, and hopefully some full member can post the links to what Refer too.


Recently, on April 18th, the FDA staff issued a briefing document for committee consideration before its vote today on Aveed (nebidio).


Google search terms:

BRIEFING DOCUMENT FOR JOINT MEETING OF
REPRODUCTIVE HEALTH ADVISORY COMMITTEE SAFETY RISK MANAGEMENT
ADVISORY COMMITTEE MEETING DATE: APRIL 18, 2013 (some terms deleted to my newbiness)


The TLDR version is there was some FDA concerns on the safety of the IM dosage/chart.

Apparently, today the FDA commission voted today 9-9 vote on the safety of Aveed (nebido) for approval. the commission also voted 17-1 negative vote on the companys suggest approach.

Oh my! it appears the company maybe in jeapardy of having pissed off the FDA.

[junk2222yard]

Here are some short articles:

Panel divided over safety of Endo's testosterone drug | Reuters
FDA Reviewers Concerned About Low-T Drug | .medpagetoday.com

and two PDFs:
AVEED Briefing Document Advisory Committee Meeting | fda.gov
JOINT MEETING FOR REPRODUCTIVE HEALTH DRUGS AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE - APRIL 18, 2013 | fda.gov