New Product Updates in Canada

From April 2008 edition of a Canadian Pharmacists Journal (CPJ).

Cubicin (daptomycin for injection by Cubist Pharmaceuticals Inc. and distributed by Oryx Pharmaceuticals Inc.) is an antibacterial agent approved for the treatment of adults with 1. Complicated skin and skin structure infections (cSSSI) caused by susceptible strains of gram-positive microorganisms such as Staphylococcus aureus, S. Pyogenes and S. agalactiae and 2) bacteremia caused by S. aureus, including right-sided infective endocarditis affecting a native valve.

‘Cymbalta’ (duloxetine hydrochloride by eli Lilly Canada Inc.) is selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved for the treatment of painful diabetic peripheral neurophathy.

‘Frova’ (frovatriptan succinate by TEVA Neuroscience) is for the acute treatment of migraine attacks with or without aura in aults.

‘Isentress’ (raltegravir by Merck Frosst Canada Ltd.) is the first in a new class of drugs known as the integrase inhibitors. It is conditionally approved in combination with other antiretrovirals for the treatment of HIV-1 infection in treatement-experienced adults who have evidence of viral replication and HIV-I strains resistant to multiple antiretroviral agents.

‘Januvia’ (sitagliptin by Merck Frosst Canada Ltd.) is the first agent to be marketed in Canada from a new class of drugs known as dipeptidyl peptase IV (DPP-4) inhibitors. It is used in combination with metformin to improveglycemic control in adults with type 2 diabetes mellitus.

‘Mezavant’ (mesalamine by Shire Canada Inc.) is a once-daily oral cormulation for the induction of remission in patients with active, mild to moderate ulcerative colitis.

‘Revlimid’ (lenalidomide by Celgene) is for the treatment of patients with transfusion dependent anemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Its approval by Health Canada is conditional, pending further studies to demonstrate clinical benefit. The agent is only available to patients registered with the controlled distribution program called RevAid. Similarly, physicians and pharmacists involved in prescribing and dispensing must also register with the program.

‘Seasonale’ (levonorgesrel and ethinyl estradiol tablets by Duramed Pharmaceuticals, distributed by Paladin Labs Inc.) is the first extended-cycle combined oral contraceptive to be marketed in Canada and is approved for the prevention of pregnancy in women 18 years and older.

‘Tridural’ (tramadol hydrochloride by Labopharm) is the third extended-release (ER) tramadol product to be marketed in Canada. This once daily formulation of the centrally acting synthetic opioid is approved for the treatment of moderately