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FDA Issues Another Warning on Fake Version of Roche (RHHBY)'s Avastin


2/7/2013 8:10:06 AM

The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung, kidney and brain. The drug was distributed by Medical Device King, which also does business as Pharmalogical. The vials are packaged as Altuzan, the Turkish version of Avastin that is not approved for use in the U.S. Similar warnings: The agency warned doctors in April about a similar case of fake Turkish Avastin distributed by a British firm. Prior to that, the FDA announced in February an investigation into a different batch of fake Avastin distributed to doctors in several states. Both of those cases appeared to involve different networks of distributors than the latest incident. The FDA said it’s currently unclear whether any U.S. patients have received the drug. Specifically, Altuzan labeled with the lot numbers B6022B01 and B6024B01 may be counterfeit. Importing even authentic Altuzan into the U.S. is illegal, since the FDA has only reviewed Avastin as safe and effective. The agency is asking doctors to stop using any products from Medical Device King, Pharmalogical or Taranis Medical, another affiliated business. A telephone number listed on Medical Device King’s website was not in service. Company representatives did not immediately respond to emails sent Wednesday.


   

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