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HDGabor

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HDGabor

Re: sts66 post# 280374

Tuesday, 06/16/2020 8:31:11 AM

Tuesday, June 16, 2020 8:31:11 AM

Post# of 427526

AFAIK Apotex doesn't have an ANDA filed with the FDA, believe they withdrew when AMRN filed the patent lawsuit

anyone think it's a little odd that only Hikma has gotten it's ANDA approved? DRL hasn't - maybe they didn't meet FDA quality or PK requirements

It is your usual AFAIK ...

- Amarin issued a PR about the recent (post 03/30) APOTEX ANDA / notice (original ANDA in 2016 was not "complete" ... P IV notice did not cover all patents)
- Hikma was the first ANDA filer ... the second (other) ANDA could not be approved due to Hikma's ANDA

SMH ...

Disclosure: I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for it.

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