Asahi Kasei Pharma is announcing that Reclast® for intravenous (i.v.) infusion 5 mg (generic name: zoledronic acid, development code: AK156) for the treatment of osteoporosis has been listed on the National Health Insurance (NHI) drug price standard as of today. In addition, the launch of the product is scheduled on November 25, 2016.
Zoledronic acid (Reclast®) is a bisphosphonate developed by Novartis (Basel, Switzerland). As an osteoporosis drug capable of a year-long treatment with once a year i.v. administration, it was first approved in 2007 in the US and EU followed by approval in over 115 countries worldwide.
Asahi Kasei Pharma received rights to develop and market Reclast® in Japan through an agreement concluded in June 2010, and obtained approval for the manufacture and sale in September this year.
Reclast® will provide a new treatment option in Japan for patients with osteoporosis.
About RECLAST®
Product name
Reclast® for i.v. infusion 5 mg
Generic name
Zoledronic acid
Indication
Osteoporosis
Dosage and administration
The usual adult dosage is 5 mg administered by intravenous infusion over not less than 15 minutes, once per year.
Manufactured and distributed by
Asahi Kasei Pharma Corp.
Date of approval for manufacturing and marketing
September 28, 2016
Date of NHI drug price listing
November 18, 2016
Date of initial marketing in Japan
November 25, 2016 (scheduled)
NHI drug price
¥39,485 per 5 mg 100 mL bottle
Reclast® is a trademark of Novartis.