Sabril's Approval With REMS No Surprise, But May Provide Marketing Advantage
This article was originally published in The Pink Sheet Daily
Executive SummaryPeriodic vision testing and a restricted distribution program will be required for Lundbeck's spasticity agent.
You may also be interested in...
A Nov. 14 advisory committee gave near-unanimous support for Vanda’s sleep disorder drug on questions about its indication, endpoints, efficacy and safety.
As Congressional markups of user fee bills looms, the agency describes actions it has taken to protect the international supply chain in its Global Engagement report; another report notes the REMS and drug safety studies it has mandated under its postmarket drug safety program.