Question-and-Answer Session
Operator
Thank you. (Operator Instruction)
And we'll take our first question from Amy Stevens with Susquehanna Financial.
Amy Stevens
Yes, good morning guys. Thanks for taking the question. I just wanted to follow-up a little bit on the DEA quota situation with regard to Vyvanse as well as the second generation; second generic API that you said will be regulated by the DEA. Can you just go into little more depth in terms of what needs to be done to resolve that situation?
Thomas D'Ambra
I think the matter is fairly simple. We were waiting for DEA quota to be able to begin manufacture of ceratin amounts of Vyvanse. We've some quota for Vyvanse, just not all the quota that will be required to manufacture all of the orders that we currently have from Shire. That also impacted some orders in 2007 that we were not able to make because we didn't have quota.
We are meeting with the DEA, Shire is also meeting with the DEA and we are working with them to get that quota. One of the issues there is that the product is ramping up and historically the DEA likes to meter out quota based on expected sales, so they look at past IMS Data and given that this product is in an early ramp up stage that’s very difficult to meter out with the expected growing demand so.
Amy Stevens
They essentially don't want manufacturing and shipping to exceed what they believe the demands for (inaudible).
Thomas D'Ambra
They are trying to closely control it. So, we and Shire are vigorously working with the DEA for that.
Amy Stevens
And what about in terms of the second generic API, it is regulated by the DEA; you said that this one is also subjected to DEA quota and that you felt that you wouldn't be able to make the amount in 2008. I guess that you had contracted for or how, what percentage of what you expected are you at or will you be at?
Thomas D'Ambra
This product that I mentioned is not in our forecast for the year. We have taken it out for our large scale forecast. This relates to a generic that we have talked about before, we partnered with a company. The DEA will not grant quota until an AMDA is approved. So, this is a case that we would be unable to make pre-launch quantities before approval, so we have to wait for the AMDA to be approved so to be conservative that we forecasted that approval will not occur this year.
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