Elite Pharmaceuticals Inc (ELTP)

[Hike]

Draft Questions for TEVA drug:

DRAFT QUESTIONS

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1. DISCUSSION: Please discuss whether there are sufficient data to support a finding that Vantrela ER (hydrocodone bitartrate extended-release tablets) has properties that can be expected to deter abuse, commenting on support for abuse-deterrent effects for each of the
three possible routes of abuse:

a. Oral
b. Nasal
c. Intravenous

2. VOTE: Should Vantrela ER be approved for the proposed indication, management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate?
3. VOTE: If approved, should Vantrela ER be labeled as an abuse-deterrent product by the oral route of abuse?
4. VOTE: If approved, should Vantrela ER be labeled as an abuse-deterrent product by the nasal route of abuse?
5. VOTE: If approved, should Vantrela ER be labeled as an abuse-deterrent product by the intravenous route of abuse?