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In addition, they were seeking FDA agreement on the acceptability of buy xanax order xanax adding a debossed marking on the tablet.

A meeting package was submitted on April 26, 2002, with details about their proposals and the teleconference focused on the questions posed in this briefing package. DISCUSSION: Since, - shelf life is important to ensure the commercial viability of Xanax XR(r) Tablets, Pharmacia & Upjohn is seeking FDA agreement that the existing stability and impurities data submitted in pending NDA 21-434 in conjunction with a accelerated stability data update in the Fall would be adequate to grant a expiry for the drug product. FDA remarked that the stability data submitted in the NDA, European data under non-ICH conditions as well as other data, was not considered to be the primary stability data critical to determining the expiration date of the product per ICH guidelines. Nevertheless, it would be considered supportive stability data. The sponsor said they will be prepared to submit time zero stability data from their facility in Puerto Rico by July 2002; however, thr^ ' - stability data update would buy xanax order xanax not be available until October 2002 which would closely coincide with the October 26, 2002, PDUFA action date of the application. The firm asked whether the review clock will be extended. FDA said that consideration will be buy xanax order xanax given to extending the review clock but that this was unlikely.

FDA concluded that they will consider all of the stability data in its between difference percocet vicodin totality in deteimining the expiration date when the primary stability data has been submitted in October 2002. The sponsor asked whether FDA has to have the primary stability data for this product. FDA said is tramadol a scheduled drug that we do need the primary stability data as the data submitted in the NDA are not for the hydrocodone manufactures market product in hydrocodone overnight delivery no prescription the proposed market container and there is no way to access the stability of the market product and its shelf-life. According to the sponsor, drug product formulation for the European stability data is similar to the proposed market product. In addition, the packaging configurations are slightly different. The sponsor plans to add' debossed markings to Xanax XR(r)Tablets and maintains that the additions of these markings is well within the range of variations that have already been studied.

The sponsor said that they plan to manufacture a validation batch of debossed tablets in f" with tire allergy hydrocodone release data available by the end of that month.



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