ELTP: Preliminary Conversational DD and the Upco
Post# of 2146
***** Note : Once Numbers 1 thru 6 have been throughly digested our Preliminary Conversation can move into the Heart of the Matter: The Second Eli 216 Patent!!
1) ELITE PHARMACEUTICALS ANNOUNCES ISSUANCE OF U.S. PATENT FOR ABUSE RESISTANT ORAL DOSAGE FORMULATION
http://www.elitepharma.com/investor_relations.asp?goto=344
*****The issuance of this patent will further protect Elite’s proprietary formulation for abuse resistant products utilizing the pharmacological approach.
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2) Guidance for Industry~Abuse-Deterrent Opioids — Evaluation and Labeling
DRAFT GUIDANCE
http://www.fda.gov/downloads/Drugs/GuidanceCo...334743.pdf
A)~Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling, explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.
Laboratory-based in vitro manipulation and extraction studies (Category 1)
Pharmacokinetic studies (Category 2)
Clinical abuse potential studies (Category 3)
B)~ Abuse deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation.
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3) Abuse Deterrent Opioids on the market currently:
A) Suboxone
B) Opana
C) Embeda
D) Oxecta
E) Oxycontin
F) Exalgo
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4) Jerry Treppel
Quote:
At this point at least one of those products is reaching the point where we expect it will go into clinical trials relatively near future.
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5) Now what will the FDA do when a Pharma company submits an Anda for an Abuse Resistant Product on the market, where the original NDA used a patented Abuse Resistant Technology such as Elite's Abuse Resistant Technology ( ART ) ???
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6) And now in relation to Number 3....Which of those drugs does Actavis not own???? And why in the World would the MOST AGGRESSIVE Generic Pharma Company in the World be interested in little old Elite anyway???
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