May 7th approval of new bol or telapriver

[somuchmore2]

Thought the fda was to approve mercks new treatment today.

Dang did i just dream that today was the date?

Or, what is latest on merck and or vertex?

[coeric]

yes as long as the doc thinks a drug might help a patient she can prescribe the drug even if it is not for an indication that is listed on the label, for example many with hepatitis c are prescribed ursodiol as a prophylaxis for primary liver cancer. yet the indicated use is primary biliary cirrhosis.  

[susan400]

It really doesn't matter what the label says or doesn't say.  Once it's approved, if your doctor wants you on it, he can write it off label.  I've had many meds prescribed this way before and I'm currently on a non-Hep C drug that is written off label.

As far as the null responder problem, that's a matter of who reads the reports.  I've had response every time I've treated, but I didn't clear.  Some of my doctors have read that as a partial response, or non-response.  Only one said it was a null response.  

Doesn't matter to me really because if I want to try Bocep and my doctor writes the script, then I really don't care what the label says.

Susan400

[coeric]

aren't these dates just a guideline and not anything set in stone? the FDA could state they need more time.  still it would be nice to see a drug released with a limited label as Andiamo1 suggested.

[Andiamo1]

My guess is that they are having label issues.  They might get an approval with a limited label, followed by a label modification in the near future.

Just a guess though.

[frijole]

Here is s link to the FDA approval -- select 05/2011 and click the submit.  I just did it and the list only goes throu 5/6.  Keep checking it -- I know I will, all day.



http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

frijole

[James10500]

Always has been, the FDA wouldn't make an announcement on a Saturday

[James10500]

It's May 23