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Wednesday, 06/29/2022 5:03:04 PM

Wednesday, June 29, 2022 5:03:04 PM

Post# of 402104
Oxycodone Hydrochloride extended release (generic version of OxyContin®)
On September 20, 2017, the Company filed an ANDA with the FDA for 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. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing, compliance with which would require significant resources. Development of this product has been reinitiated with a target filing in Q1 2023
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