EpiPen Therapeutic Equivelency

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ColeSnow

#1
Hello Everyone,

New to this forum and I hope I'm posting in the correct place.

From my understanding, there is no therapeutic equivalent device for the EpiPen.

Per FDA guidance, there are few requirement for therapeutic equivalence. Being that the drug in the EpiPen is Epinephrine it would seem that multiple products on the market would be equivalent. Is there something I am overlooking?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove!

I'm not sure I understand the context of your question. Under what FDA process are you looking for a "therapeutic equivalent"?

Further, I had a look at the Orange Book and it seems like at least 2 devices should be equivalent - AUVI-Q and ADRENACLICK - because they have the same active ingredient (Epinephrine), the same dosage form (injectable), the same route of administration (intramuscular, subcutaneous) and the same strength (0.3mg/delivery) as the Epipen. Why are you stating that there are no therapeutical equivalents?

Disclaimer: I'm into medical devices regulations more than into drugs ones.
 
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C

ColeSnow

#3
Hi Ronen,

Yes, those are the two devices I had in mind and I agree that they have the same active ingredient, dosage form, route of administration, and strength. However, they are given the therapeutic equivalency code of BX.
 

Miner

Forum Moderator
Staff member
Admin
#4
Hi Ronen,

Yes, those are the two devices I had in mind and I agree that they have the same active ingredient, dosage form, route of administration, and strength. However, they are given the therapeutic equivalency code of BX.
Clarification of BX code.
 

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