TopoTarget gains FDA marketing approval of its first drug  

2007.09.10
TopoTarget has received FDA approval to market Totect, a damage-limiting agent for use following accidental leakage into surrounding tissue of injected anthracycline anti-cancer drugs
Danish biopharmaceutical company TopoTarget has received FDA approval in the US to market its product Totect, a damage-limiting agent for use following accidental leakage into surrounding tissue of injected anthracycline anti-cancer drugs. In October 2006, Totect was launched in Europe under the Savene brand. Totect/Savene has Orphan Drug status* in Europe and the US.
 
Peter Buhl Jensen, managing director of TopoTarget says: "I am delighted that US patients will now benefit from our product. I am proud of TopoTarget and the fact that our unique treatment for this feared accident has now gained FDA approval. It is a breakthrough for TopoTarget and for Danish biotech as a whole."
 
TopoTarget has established a US subsidiary and is ready with its own sales force to launch Totect on the American market.
 
TopoTarget is headquartered in Denmark, and has subsidiaries in UK, Germany, Switzerland and the US. The firm has a broad portfolio of small molecule preclinical drug candidates, and has eight drugs in clinical development including novel anti-cancer therapeutics. Totect/Savene is TopoTarget's first product on the market. The news was reported by financial daily newspaper Børsen and on TopoTarget's website.
 
* status given to products developed for rare, serious diseases, which gives the manufacturer tax reductions and market exclusivity for a period of at least 7 years post-approval in order to make such product development financially worthwhile – Ed.
 
 
Link > TopoTarget   

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