CPhI Online

Pipeline - Lacosamide Oral Solution Product Profile

13 Apr 2021

Lacosamide 10mg/ml Oral Solution
Reference Product: Vimpat® / UCB

Description: Lacosamide is a functionalised amino acid which belongs to the group of antiepileptics. Lacosamide is used as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Dossier Status: On-going / EU CTD Available: Q2 2022
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Sizes: 970 Bottles
Pack Sizes: BT x 1 Glass Bottle