Replies to post #239563 on Elite Pharmaceuticals Inc (ELTP)

[lasers]

For the Oxycontin ANDAs submittals FDA could also give "Tenative Approval" more quickly in 2017 and then Approval when last remnant of Purdue's frivolous claims extensions expire in 2018 or sooner.

[WeeZuhl]

That is what I was thinking, too.

By the time Elite submits the ANDA, the timing for an expected response from the FDA would be around the Aug '18 timeframe.

I like the below graph from the FDA. It shows in bar graph form the status of all ANDAs as of January 2015 using their current review cycle procedures.



http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM442070.pdf]