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rafunrafun

05/23/20 12:36 PM

#275791 RE: Insync_2000 #275764

In2000 - authorized generic would be our worst case scenario.

A generic drug is the same as the brand-name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. ... An authorized generic drug is the same as the brand-name drug but does not use the brand name on the label.


https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs


An example:

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/8/authorized-generics-why-mylan-would-compete-with-itself-in-the-epipen-market

sts66

05/23/20 4:46 PM

#275877 RE: Insync_2000 #275764

AMRN does not control supply - there are suppliers that AMRN isn't using (BASF, Nissui), and even AMRN's API suppliers can sell to the highest bidder if someone wants to pay more than AMRN.