ApprovalTrail

Approval · Notice of Compliance 9040 · 2007

CUBICIN: Notice of Compliance 9040

Issued September 24, 2007

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
9040
Date
September 24, 2007
Company
Cubist Pharmaceuticals Llc6005 Luzern, Luzern, Switzerland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided staphylococcus aureus infective endocarditis (native valve) caused by methicillin-susceptible and methicillin-resistant strains
Therapeutic class
Antibacterial agent

Products in this notice

BrandDINStatus today
CUBICINNot yet assigned—

Medicinal ingredients