Approval · Notice of Compliance 25354 · 2021
VIIBRYD: Notice of Compliance 25354
Issued March 5, 2021
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 25354
- Date
- March 5, 2021
- Company
- Allergan IncMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update the labelling to include information on the use of vilazodone in the pediatric population (7-17 years of age) based on three Phase 3 clinical studies in pediatric patients and to request an extension to the data exclusivity period based on these clinical studies.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VIIBRYD | Not yet assigned | — |
Medicinal ingredients
- VILAZODONE HYDROCHLORIDE 10 MG per TAB
- VILAZODONE HYDROCHLORIDE 20 MG per TAB
- VILAZODONE HYDROCHLORIDE 40 MG per TAB