Posted by Michael Wonder on 10 Aug 2018
Ironshore Pharmaceuticals announces FDA approval of Jornay PM (methylphenidate) extended-release capsules CII for the treatment of ADHD
9 August 2018 - The commercial launch of Jornay PM is planned for the first half of 2019.
Ironshore Pharmaceuticals announced today that the U.S. FDA has approved the new drug application for Jornay PM (methylphenidate) (formerly known as HLD200) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older.
Jornay PM is a novel formulation of methylphenidate which is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day. JORNAY PM is the first drug utilizing Ironshore’s proprietary drug delivery platform, Delexis.
