Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

their other products filed for approval has been sitting for years? FDA approval is supposed to be 10 months.

You're confusing ANDA submissions with NDA submissions.

NDA submissions are accepted or/not within 30 days from filing and given a PDUFA date which is 10 months from date of filing... unless it has been given AA - accellerated approval status in which case it's then 6 months rather than 10 months.

ANDA applications are NOT given a specific date as to when they will/or/not be approved... although that I believe is slated to change in 2018... and can be anywhere from around 2 years to 8 years.

They do however prioritize these applications and will approve those drugs they feel will introduce competition and drive down prices - which is the whole idea of generics.

Based on that, it's safe to assume that if our Seroquel XR has a paragraph 4 on the 400 mg - which I believe it has, then we should get approval on that strenght by november ? of this year, and tentative approval on all other strenghts 6 months thereafter.