Elite Receives FDA Approval for Hydrocodone, Acetaminophen Combo

Elite Pharmaceuticals announced that it received approval from the U.S. Food and Drug Administration (FDA) for the company’s abbreviated new drug application (ANDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $447 million according to IQVIA data.

"This is our fourth product approval in 2018 with four additional ANDAs and an NDA for SequestOx currently filed with the FDA," stated Nasrat Hakim, President and CEO of Elite. "Hydrocodone/acetaminophen is a strategic addition to Elite’s pain medicine portfolio.  The acetaminophen creates irritation if the product is crushed and taken intranasally, thereby potentially providing some intranasal abuse-deterrence according to the FDA."

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