Elite Pharmaceuticals Inc (ELTP): Also, if you are the first to file , you...

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Re: NASDAQ2020 post# 382055

Monday, 07/03/2023 7:43:21 AM

Monday, July 03, 2023 7:43:21 AM

Also, if you are the first to file , you get 180 start on everybody else, If I'm reading this right

Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.

from this link:
https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals

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