Health Canada asks for quarantine of drugs from Indian plant under investigation

From the Canadian Press:
An Indian pharmaceutical firm has agreed to a Health Canada request to quarantine all drugs coming into Canada from a manufacturing plant alleged to have falsified data and test results.

Health Canada said Thursday that Ranbaxy Canada has agreed to place a hold on all drugs coming into the country from the Paonta Sahib manufacturing facility.

Health Canada revealed the move in a brief end-of-day email in response to questioning from The Canadian Press.

The questions were provoked by a statement issued Wednesday by the U.S. Food and Drug Administration. The FDA said it was halting review of new drug applications involving the Paonta Sahib plant because it had evidence of data falsification.

Health Canada provided no details of how many or what type of drugs Ranbaxy Canada imports to this country. Nor did it offer advice to people who might be taking those drugs.

"Health Canada is taking appropriate actions to mitigate the potential risks to the health and safety of Canadians," said the response, sent by spokesperson Alastair Sinclair.

"Following Health Canada's request, Ranbaxy Canada has quarantined all products imported into Canada from the Paonta Sahib site." ...more

India's Ranbaxy hit by reports of Canada drug review

From AFP:
Shares of Indian generics giant Ranbaxy hit an 18-month low Tuesday on reports Canada was looking into the safety of the firm's drugs as well as on fears about its revenue outlook, analysts said.

Ranbaxy shares have been under pressure since the US Food and Drug Administration blocked imports of over 30 of the New Delhi-based company's drugs last week, saying they failed to meet manufacturing standards.

On Tuesday, India's business daily Mint quoted the Canadian health ministry as saying a "regulatory letter" was sent to Ranbaxy Pharmaceuticals Canada requesting an action plan and a response to the FDA's move.

The company, which is being bought by Japan's Daiichi Sankyo in a deal valued at up to 4.6 billion dollars, closed down 11.05 percent or 38.35 rupees at 308.85 rupees, its lowest level since March 2007.

"We're not responding to any media reports," said a spokesman for Ranbaxy when asked about the Canadian letter. ...more

Pfizer Wins Canadian Order Blocking Generic Version of Lipitor

From Bloomberg:
Pfizer Inc., the world's biggest drugmaker, won a Canadian appeals court ruling blocking regulatory approval of Ranbaxy Laboratories Ltd.'s generic version of the cholesterol pill Lipitor.

Canada's Federal Court of Appeal yesterday reversed a lower-court ruling that Ranbaxy could seek approval for its competing version of Lipitor before Pfizer's patent expires in 2010, Pfizer spokeswoman Vanessa Aristide said in a phone interview.

Ranbaxy, India's largest drugmaker, also challenged Lipitor patents in the Netherlands. Pfizer said in February it would appeal a Dutch ruling invalidating one of its patents covering Lipitor, the world's best-selling medicine with ales of $12.7 billion last year. Ranbaxy can appeal yesterday's ruling to Canada's Supreme Court. The order doesn't apply to litigation in other countries, including the U.S., Aristide said. ...more

Fentanyl pain patches recalled in Canada

From CTV News:
In the latest of several alerts on the safety of fentanyl pain-relief patches, Health Canada has announced the recall of two brands of the powerful patches.

The agency advises against using:

* 25 mcg/hr Duragesic (fentanyl transdermal system) patches sold by Janssen-Ortho Inc.
* 25 mcg/hr Ran Fentanyl Transdermal System patches sold by Ranbaxy.

Both products are being voluntarily recalled because they may have a cut along one side of the patch that could result in leaking of the fentanyl gel from the patch.

"Exposure to fentanyl gel that has leaked from the patch may lead to increased skin absorption and could result in serious, potentially life-threatening adverse events, including respiratory depression (slowed breathing) and possible overdose, which may be fatal," Health Canada said in its warning. ...more