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Re: alternatepatel post# 16629

Sunday, 02/12/2017 12:16:16 PM

Sunday, February 12, 2017 12:16:16 PM

Post# of 20689
alternatepatel,

Upon further research it looks like the FDA recieved its first submission much earlier, on Feb 26, 2014.

Glatiramer Acetate Injection 40 mg/mL,pre-filled syringe Copaxone 2/26/2014

That means that whoever filed it did not notify Teva at the same time. It looks like Reddy was the one who alerted Teva of it's intentions.

Maybe dew could explain while they didn't alert Teva back in Feb to start the 30 month clock.

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM293268.pdf