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Zogenix Approval Sheds Light On Path For Elite Pharmaceuticals

The recent approval of a reformulated version of Zohydro has shed some light on the path that Elite Pharmaceuticals (ELTP) may be taking to garner approval. Elite Pharma noted to investors in November that some additional but small studies/trials may be needed prior to the submission of a 505B2 NDA for Eli-200. This is the first of seven abuse-deterrent opioid products by Elite that are in development. Three have already been trialed, including Oxycontin.

In my article titled "Elite Pharmaceuticals Is Well Positioned To Address $7B Abuse Deterrent Market", I go into detail about Elite's progress over the past year and how they have once again become a significant player in the ADT market. On January 30, when it was announced that the FDA had granted approval for a reformulated version of extended-release hydrocodone bitartrate named Zohydro, investors like myself were very interested in the path the… Read More …