Elite Pharmaceuticals Inc (ELTP)

[elichen]

FACT: the T-max "safety issue” for SequestOx is exactly the same for all IR opioids, whether ADF or non-ADF. (And similarly to many other kinds of drugs. Shall the FDA recall all those previously approved drugs)???

That is why all FDA approved NDA and ANDA IR and ER Oxymorphones come with the same instructions : "should be taken on an empty stomach, at least one hour prior to or two hours after eating. TAKE no more than 2 pills every 4 hours”.

Simple labeling fix and this fix was told to ELTP by FDA in 2014.