News 
Market Data 
Discover
Replies to post #220626 on Elite Pharmaceuticals Inc (ELTP)
08/09/16 4:35 PM
Filing of ANDA for a generic version of Percocet®
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain.
08/09/16 4:44 PM
08/09/16 4:51 PM
"ELI-202 we "started " out utilizing our Nalrexone sequestered technology with an oxy/APAP combination . We moved thru the trials and then Dr Hertz at the FDA notified us, stating that it is highly unlikely that they would give anyone the labeling for a product that has APAP in it because, they(FDA) considers APAP to be the abuse deterrent. As a mater of fact the FDA guidance that came out in 2015 indicated that Oxy/APAP and Hydro/APAP are products that are NOT abused nasally or via IV injection. Snorting is not a desired route people use. They use them Orally, why because the APAP is an irritant, it irritates your nose, not snorted.
Therefore adding naltrexone which is an Expensive substance, and cost another $15 million dollars in clinical trials, it gives us NO EDGE over just using APAP.
We want to be competitive in this category but we also want to be intelligent and NOT waste our money on anything that is not going to get us Preferred a labeling.
We do expect to develop additional ADF products in this arena. . . ."
