Grifols said that approval from the US Food and Drug Administration (FDA) for Flebogamma 10% DIF was obtained in July 2010 and final approval in Europe is expected before the end of the year.
Grifols US Operations president Gregory Rich said that they were excited about being able to meet a clinical needs by providing healthcare providers and patients the additional treatment option of Flebogamma 10% DIF.
Grifols stated that the approval and launch of Flebogamma 5% DIF in early 2007, ushered in a new standard in IVIG treatment with the development of a dual inactivated, nano-filtered (DIF) product.
Development of the DIF production process was the result of more than a decade of research and the construction of IVIG production facilities in Barcelona, Spain.
Grifols claimed that like all Grifols’ products, each vial of Flebogamma 10% DIF is laser etched with an identification number to ensure product integrity and additionally, the outer packaging is secured with a tamper evident holographic overseal containing specialised printing to confirm authenticity.