Approval · Notice of Compliance 17224 · 2015
KALYDECO: Notice of Compliance 17224
Issued June 12, 2015
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
- 17224
- Date
- June 12, 2015
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- To expand the indication of kalydeco for the treatment of cystic fibrosis in patients from 6 years and older to 2 years and older who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: G551d, G1244e, G1349d, G178r, G551s, S1251n, S1255p, S549n, S549r or G907r
- Therapeutic class
- Cystic fibrosis transmembrane conductance regulator (cftr) potentiator