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Home Industry News GlaxoSmithKline product receives FDA approval

GlaxoSmithKline product receives FDA approval

24th November 2008

GlaxoSmithKline has said it has received approval by the US Food and Drugs Administration (FDA) for its Promacta (Eltrombopag) product.

The drug is used as an oral medication to increase platelet production for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), who have an insufficient reponse to immunoglobulins, corticosteroids or splenectomy.

GlaxoSmithKline said it expects Promacta to be available this week.

Craig Conway, executive director of the Platelet Disorder Support Association, commented: “It is very important for chronic ITP patients to have new treatment options to manage the symptoms of this serious and, at times, life-threatening disease.”

“[The] new product represents a promising new treatment option that offers hope”, he continued.

Mr Conway added people with the condition are concerned about everyday activities, as a bump or a bruise may lead to bleeding.

Approximately 60,000 people in the US have chronic ITP.

It is a disorder which sees increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding.

GlaxoSmithKline employs 100,000 people in over 100 countries, of which 15,000 people work in product research.

The company makes almost four billion packs of medicines and healthcare products every year and its brands include Aquafresh, Lucozade, Zovirax, Ribena, Horlicks, Sensodyne and Panadol.

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