Posted by Michael Wonder on 09 Jun 2016
TGA publishes AusPAR for Nuvigil (armodafinil)
9 June 2016 - The TGA has published an AusPAR for Teva's Nuvigil (armodafinil).
Armodafinil was approved by the TGA on 24 November 2015:
- To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy;
- To treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate;
- As an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.
For more details, go to: http://www.tga.gov.au/auspar/auspar-armodafinil
