recall a major shut down storm early November and a Federal holiday this week ...
"1. How often is the Orange Book updated?
Since February 2005, we have been providing daily Electronic Orange Book (EOB) product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic products which is important for substitution purposes. Previously, a first-time-generic product approved early in the month would not be published in the EOB for several weeks.
The monthly EOB update goal is by the end of the following month’s second work week (e.g., November’s EOB will be updated by the end of the second full work week in December). "
The Federal Government including the FDA in the DC area shut down for 2 days due to the Hurricane. Looking at the Sep & Oct OB updates due to holidays... I suspect we'll get the update on or around 11/21.
If you guys think the FDA still has no decision, I would agree. Only problem is that they have had since August to figure this out. Enough of this crap! Give us A) yes, B)no, or C)go f yourself. I vote for A or B. We all want to move on, FDA is a slow moving government slug. Please get off your bum and say something!? Am I way off base?
OK, so you are telling me that, the FDA will make a decision by Nov 16 BUT we will only see it after 3-4 weeks in Electronic Orange Book? Can you have 10-20 people or more in FDA know the result and have no leak of these news in 3-4 weeks? That's impossible!