Regulatory Affairs

Elite secures FDA approval for generic Percocet pain tablets

Published 05 July 2018

Elite Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets.

This product is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Based on QuintilesIMS Health data for the twelve months ending May 31, 2018, the retail sales for the brand and generic products were approximately $500 million.

Elite president and CEO Nasrat Hakim said: “Oxycodone with Acetaminophen is a strategic addition to our expanding product line.  It is an immediate release opioid product used extensively by doctors today in pain management.  According to the FDA, if the product is crushed and taken intranasally the Acetaminophen creates irritation in the nasal passages and may thereby provide some intranasal abuse-deterrence.

“Elite is committed to developing niche generic products and a diverse range of opioid abuse-deterrent products that incorporate our proprietary sequestration technology and other abuse-deterrent products, such as Oxycodone and Acetaminophen tablets that are niche generic drugs.  We currently have five products filed with the FDA and we look forward to additional product approvals in 2018.”

Source: Company Press Release