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Thursday, 05/25/2017 4:33:17 AM

Thursday, May 25, 2017 4:33:17 AM

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*** 90% Chance Generic Percocet FDA Approval WITHIN 16 days ***


Elite Pharmaceuticals Files ANDA To Market Generic Percocet

NORTHVALE, N.J., Aug. 10, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain. Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.

FDA this fiscal year will begin to “review and act on 90 percent of complete electronic ANDAs within 10 months after the date of submission.”




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