Novartis and Novo Nordisk gain Australian orphan status
This article was originally published in Scrip
The Australian Therapeutics Goods Administration (TGA) has granted orphan status to drugs from both Novartis and Novo Nordisk this month.
Novartis's Zometa (zoledronic acid), 4mg powder for injection and 4mg/5ml concentrated injection, was approved as an orphan drug on May 8th, for the treatment of paediatric patients with severe osteogenesis imperfecta.
Novo Nordisk's Norditropin Simplexx (somatropin) injection solution, and accompanying Norditropin Nordiflex pen, were also granted orphan status. These products gained the status for the treatment of Prader-Willi syndrome.