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Re: Rocky3 post# 121773

Friday, 06/17/2011 2:00:09 AM

Friday, June 17, 2011 2:00:09 AM

Post# of 257265

Has anyone seen approvals "come out of the blue" on other drugs under paragraph 3?

Yes, Paragraph-3 is the main approval path for US generic drugs. Such approvals can be “out of the blue” because there is no need for the applicant to notify anyone (as there is with Paragarph-4 submissions).

A Paragraph-3 submission could conceivably be pending for Lovenox, but that’s quite unlikely, IMO.

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