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Extraction Summary

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People
7
Organizations
2
Locations
4
Events
2
Relationships
3
Quotes

Document Information

Type: Investment research report / legal analysis (page 75)
File Size: 2.35 MB
Summary

This document is page 75 of a 2017 report by Ackrell Capital, LLC, titled 'Chapter IV U.S. Legal Landscape.' It details FDA regulations regarding 'off-label' prescriptions and specifically analyzes 'Cannabinoid-Based Drugs' such as Marinol, Syndros, Cesamet, Sativex, and Epidiolex. It discusses their scheduling under the Controlled Substances Act (CSA) and the status of their FDA approvals as of October 2017. The document bears a 'HOUSE_OVERSIGHT_024711' stamp, indicating it was part of a document production for the House Oversight Committee.

Timeline (4 events)

1985
FDA approval of Marinol and Cesamet
USA
FDA
1992
Marinol approved for treatment of anorexia associated with AIDS
USA
FDA
2016
Syndros approved by the FDA
USA
FDA
October 2017
NDA for Epidiolex submitted to the FDA
USA

Locations (2)

Location Context

Relationships (2)

GW Pharmaceuticals Manufacturer/Product Sativex
Sativex and Epidiolex (both manufactured by U.K.-based GW Pharmaceuticals)
GW Pharmaceuticals Manufacturer/Product Epidiolex
Sativex and Epidiolex (both manufactured by U.K.-based GW Pharmaceuticals)

Key Quotes (3)

"A drug generally may not be marketed for treating a condition other than a condition for which the FDA has found the drug to be a safe and effective treatment"
Source
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Quote #1
"The FDA has not approved any drug derived from the cannabis plant."
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Quote #2
"If approved by the FDA, Epidiolex would be the first FDA-approved pharmaceutical derived from cannabis."
Source
HOUSE_OVERSIGHT_024711.jpg
Quote #3

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