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Re: fabius post# 37021

Wednesday, 10/03/2018 8:29:15 AM

Wednesday, October 03, 2018 8:29:15 AM

Post# of 38634

2 - ADFs are an invariant, just a bunch of reaserch and money thrown away and therefore better to be removed from to avoid costs to the society





This is an unusually adept conclusion from you. One could argue that the lack of evidence showing ADF's save lives is an important reason why ADF's were never mandated by law and why now 6 drugs with an ADF label are listed as discontinued in the FDA Orange Book.









ADF #6 was discontinued just last week:



http://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=12475646&type=HTML&symbol=EGLT&companyName=Egalet+Corporation&formType=8-K&dateFiled=2018-09-28



On September 28, 2018, Egalet Corporation (the “Company”) notified the U.S. Food and Drug Administration that, for business reasons, the Company is discontinuing the manufacture and promotion of Arymo® ER (morphine sulfate) extended-release tablets (“ARYMO ER”) effective September 28, 2018 (the “Discontinuation”). As part of its notice, the Company requested that the Orange Book staff move ARYMO ER to the “Discontinued Drug Products List” of the Approved Drug Products and Therapeutic Equivalence Evaluations (Orange Book) publication, and that the User Fee staff note the discontinued status of the product.










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