Elite Pharmaceuticals Receives FDA Approval For Codeine And Acetaminophen Combo

Elite Pharmaceuticals, Inc. ("Elite" or the "Company") a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, recently announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Tylenol with Codeine (acetaminophen and codeine phosphate) 300mg/15mg, 300mg/30mg, and 300mg/60mg tablets.

About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic products which have been licensed to TAGI Pharma, Glenmark Pharmaceuticals, Inc., USA., and Lannett Company, Inc. Elite currently has thirteen approved generic products, three generic products filed with the FDA, one approved generic product pending manufacturing site transfer, and an NDA filed for SequestOx™. Elite's pipeline products include abuse-deterrent opioids which utilize the Company's patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. Learn more at www.elitepharma.com.