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jadite

12/07/16 5:55 AM

#6135 RE: dasgrunt #6134

Thanks dasgrunt. This is just a stab at an answer: page 14 shows a flow chart indicating 6 months minimum for prior approval supplement. If so, any time now.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf
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Just the facts maam

12/08/16 6:08 PM

#6136 RE: dasgrunt #6134

Dasgrunt, I have been watching for the launch as well. They have not announced a launch and it is not listed on their product list. But you are correct that the announcement should be soon. Later this month or next, if consistent with the timelines of other launches post approval.