Abuse deterrent C-II

Started by ZakMeister
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ZakMeister

RPh
10+ Year Member
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Just to be clear...are any of the C-II opioid generic abuse deterrent? My knowledge and research suggests NOT and FDA are in the process of releasing a guidance for the mftrs to make such. On the similar note, I wonder then why we can substitute Oxycontin with oxycodone ER since Oxycontin is abuse deterrent and the generic is NOT ?
 
The only ones on the market are authorzied generics, i.e., same as OxyContin, different labeler like Teva. So when you are doing a "substitution" in the system, it actually is not a true substitution as the manufacturer is the same

An example of a generic that is not putatively abuse deterrent is oxymorphone ER (Global/Impax) as that ANDA is based off the original Opana ER formulation.
 
The only ones on the market are authorzied generics, i.e., same as OxyContin, different labeler like Teva. So when you are doing a "substitution" in the system, it actually is not a true substitution as the manufacturer is the same

An example of a generic that is not putatively abuse deterrent is oxymorphone ER (Global/Impax) as that ANDA is based off the original Opana ER formulation.
MD wrote a rx stating clearly “oxycodone ER 80 mg abuse deterrent formumation” and i was confused as only MS contin was abuse deterrent.
 
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Just to be clear...are any of the C-II opioid generic abuse deterrent? My knowledge and research suggests NOT and FDA are in the process of releasing a guidance for the mftrs to make such. On the similar note, I wonder then why we can substitute Oxycontin with oxycodone ER since Oxycontin is abuse deterrent and the generic is NOT ?

They are literally the same pills
 
I don't know if it meant anything. All I know is when they started shipping I got millions of phone calls asking if I "got any OC's?" as the OP's "bothered [everyone's] stomach."
buy 'bothers their stomachs' they really mean the geriatrics weren't able to sell their new uncrushable, uninjectable oxypills for as much cash to the local addicts like normal so they can fund their multi-decade losing streak at video poker at the local casino? right?