The US Food and Drug Administration (FDA) has approved Elite Pharmaceuticals Inc's (OTCBB:ELTP) abbreviated new drug application (ANDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg tablets, the company said on Tuesday.
This product is a combined opioid/non-opioid pain reliever used to treat moderate to severe acute pain. It is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
According to the FDA, if the product is crushed and taken intranasally the Acetaminophen creates irritation in the nasal passages -- providing some deterrent against abuse.
QuintilesIMS Health data for the 12 months to 31 May 2018 show that retail sales for the brand and generic products were approximately USD500m.
Elite currently has five products filed with the FDA and anticipates further approvals in 2018.
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