updates, always updates, page-17

SNI4,
you are correct the contamination issues are not related to Reddy's or ACL at all. Reddy's have regular approvals and had a recent approval last week. The successful completion of the preapproval inspection discounts any fears from that perspective.

Gogo159,
on what basis do you think the approval will drag on to mid year?

If you look at the flow chart of the ANDA review process on the FDA site it is quite succinct with four major steps to be completed, the big boxes to be ticked as PS has described it, and they have been ticked. In ACL's case and based on the communication we have received to date ANDA 91316:
Box 1. ANDA lodged March 09
Box 2. ANDA filing acceptable and complete May 09
Box 3. Review by OGD/CDER completed approximately July 10
Box 4. Preapproval inspection successfully completed Feb 11

The major hold up in the process has been the time lag, 8 mths, to get FDA inspectors on site to complete the preapproval inspections. With this now done if you refer back to Review process there is no other step to complete, in fact there is just a flow arrow to a box called ANDA approved.

So in essence you are saying that is going to take another 4 to 6 mths to get into an intray and be stamped and faxed. If you have some other information, other than the FDA are very slow, for your forecast time lag until approval could you let us know.

It is quite apparent that the delays have all been caused by a lack of manpower at the FDA, fortunately manpower is not the issue anymore for ANDA 91316.