Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release

Elite Pharmaceuticals filed an abbreviated new drug application with the FDA for a generic version of OxyContin.

Elite Pharmaceuticals (OTCBB:ELTP) filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin.
As quoted in the press release:

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.”

Click here to read the full press release.

Source: globenewswire.com

fda food and drug administration generic generics new drug application opioid abuse opioid treatment oxycontin pain us Pharmaceutical Investing