SODIUM OXYBATE-REACH (Reach Pharmaceuticals Pty Ltd)
Product name
SODIUM OXYBATE-REACH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
sodium oxybate
Registration type
NCE/NBE
Indication
Treatment of narcolepsy in adult patients, adolescents and children from the age of 7 years.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.