Elite Pharmaceuticals Inc (ELTP)

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Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
GLOBENEWSWIRE 8:38 AM ET 9/20/2017
Symbol Last Price Change
ELTP 0.0952down 0 (0%)
QUOTES AS OF 03:07:59 PM ET 09/19/2017
NORTHVALE, N.J., Sept. 20, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.(ELTP) ("Elite" or the “Company") announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.


“I am very pleased with this filing of an ANDA for a generic version of OxyContin®. This is our fourth ANDA filing in the past 15 months and is a key addition to our portfolio,” said Nasrat Hakim, President and CEO of Elite. “Elite is committed to developing a diverse range of opioid abuse-deterrent pain products and attractive niche generics.”

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