Approval of additional bag formulation of Reclast® for i.v. infusion 5 mg
August 10, 2022
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma today obtained approval for the manufacture and sale of Reclast® for i.v. infusion 5 mg (generic name: zoledronic acid hydrate) as a bag formulation, for the treatment of osteoporosis in Japan.
Reclast® is a bisphosphonate developed by Novartis Pharma AG (Basel, Switzerland). Asahi Kasei Pharma obtained a license to develop and market Reclast® in Japan, and began selling it in November 2016 as an osteoporosis drug capable of a year-long treatment with once-a-year intravenous administration.
While Asahi Kasei Pharma has provided Reclast® as bottle formulation containing 5.0 mg zoledronic acid hydrate in a 100 mL bottle, the newly approved bag formulation is expected to offer greater convenience in use by allowing easy disposal of the used container and eliminating the need for an air needle.
About Reclast® in both bottle and bag formulations
- Product name
- Reclast® for i.v. infusion 5 mg
- Generic name
- Zoledronic acid hydrate
- Indication
- Osteoporosis
- Dosage and administration
- The usual adult dosage is 5 mg administered by intravenous infusion over no less than 15 minutes, once per year.
Reclast® is a trademark of Novartis Pharma AG.