Canada rejected nevirapine twice, once in 1996 and again in 1998, after the drug showed no effect on so-called surrogate markers (HIV viral load and CD4 counts) and was alarmingly toxic.
A Google search quickly showed that nevirapine is currently approved in Canada, so I called the Canadian Department of Health and they said that I could cite this:
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Created on: 09/15/1998 Nevirapine receives green light from Health Protection Branch On Friday 03 September, 1998, Canada's Health Protection Branch (HPB) granted a conditional Notice of Compliance to Boehringer Ingelheim's anti-HIV drug nevirapine (Viramune). Nevirapine belongs to a class of drugs known as NNRTIs (non-nucleoside reverse transcriptase inhibitors) and is related to the drugs delavirdine (Rescriptor) and efavirenz (Sustiva). As part of the conditional approval process, Boeringer must submit additional efficacy and safety data on nevirapine from ongoing and planned studies to HPB. Those people receiving nevirapine through an expanded access protocol will continue to do so until the end of the year, by which time the cost should be covered by provincial formularies.
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Dear Mr. Foley,
I am responding to your medical information request about the approval process in Canada for Viramune. The initial application was filed with Health Canada in June of 1996 and it was rejected. The application was re-submitted to Health Canada in 1998, and in September of that year Health Canada granted conditional approval for the drug. The authority requested quarterly updates and additional clinical data to consider before granting traditional full approval in Canada. The application for traditional approval and additional data was submitted to the authority in July 2001 and full approval was granted in 2004.
Regards,
Medical Information
Boehringer Ingelheim Canada Ltd.
Dear Mr. Foley,
I would like to inform you of a correction of the information you were supplied with yesterday. The company's Drug Safety and Regulatory Affairs Department notified me today that the initial application for Viramune in Canada was never rejected. Instead, the initial application went to Health Canada in June 1996 and conditional approval for the drug was granted in Sept 1998. The authority requested quarterly safety updates and additional clinical data to consider before granting traditional full approval in Canada. The application for traditional approval and additional data was submitted to the authority in July 2001 and full approval was granted in 2004.
I apologize for the miscommunication earlier and any inconvenience it may have caused.
Regards,
Medical Information
Boehringer Ingelheim Canada Ltd.
