Elite Pharmaceuticals Receives FDA Approval for Generic Percocet

Elite Pharmaceuticals has received approval of the company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg 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.

"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," said Nasrat Hakim, President and CEO of Elite. "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."

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