CORRECTED - CORRECTED-UPDATE 1-FDA warns Bioniche Pharma on Sotradecol misbr

Tue Sep 29, 2009 7:26pm BST
 
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(Corrects to say FDA issued warning letter to Bioniche Pharma, not Bioniche Life Sciences Inc. Also removes reference to share price)

* Sends warning letter about "false or misleading" info

* Warning over web pages of Bioniche Pharma, AngioDynamics

* Seeks corrective action

Sept 29 (Reuters) - U.S. health regulators issued a warning letter to Bioniche Pharma USA LLC for publishing "false or misleading" information on Sotradecol, its drug to treat varicose veins.

Certain web pages of Bioniche Pharma and distributor AngioDynamics Inc (ANGO.O) present efficacy claims for Sotradecol but fail to communicate any information about the risks associated with the product, the U.S. Food and Drug Administration (FDA) said in a letter to the company.

The web pages also broaden the approved indication for Sotradecol and overstate its efficacy, the FDA added.

The FDA said it is very concerned by the company's continued violative promotion of this product. Bioniche Pharma was cited for the same violations in a letter in April 2006, it said.

The agency also warned that failure to correct the violations may result in regulatory action, including seizure or injunction, without further notice. (Reporting by R. Manikandan in Bangalore; Editing by Unnikrishnan Nair)

 

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