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Regulatory Focus™ > News Articles > Counterfeit Avastin Found in US, Warns FDA

Counterfeit Avastin Found in US, Warns FDA

Posted 15 February 2012 | By Alexander Gaffney, RAC 

Counterfeit copies of Roche Holding AG's anticancer drug Avastin (bevacizumab) have been found in the US, the US Food and Drug Administration (FDA) warned on 14 February.

According to investigators at Genentech, a subsidiary of Roche, the counterfeit copies did not contain the active pharmaceutical ingredient (API) that makes the drug safe and effective for its approved indications.

Reporting by TheWall Street Journal indicates that supplies of the counterfeit product were obtained from unauthorized sources. "Genentech limits the distribution of many of its products and only sells its products directly to a defined number of fully licensed and contracted wholesalers and specialty distributors," said a Genentech spokeswoman to The Wall Street Journal.

FDA's letter further indicated that 19 medical practices-primarily based in California-had potentially purchased the counterfeit supplies. FDA sent out letters on 14 February to those medical practices alerting them of the issue.

The counterfeit product-Avastin 400mg/16mL-costs $2,400 per dose, making it an attractive target for counterfeiters.


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