Saturday, August 29, 2015 1:09:16 PM
An example of why it will be important to try and get up front approval for all doses on initial patents and FDA approvals. Different patients and diseases require different amounts of IVig drugs. Need to make the case up front to avoid years of litigation on each dose.
"Grifols, a leading provider of plasma-derived therapies, announced today that the 40-g (400 mL) vial size for GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) became available on November 3 in the United States.
With the addition of the new 40-g vial, GAMUNEX-C now comes in 6 different vial sizes, including 1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL)—the widest range of vial sizes currently available.
The wide range of vial sizes helps avoid unnecessary waste and provides an easier, more convenient way to dose according to prescription.
The addition of a 40-g vial is welcomed by both the nursing and patient communities. Jan E. Jones R.N., President of Immunoglobulin Nursing Society (IgNS) said, “The convenience of the new 40-g vial size for GAMUNEX-C will mean less time for preparation of IVIG."
GAMUNEX-C offers versatility with proven efficacy in 3 FDA-approved indications: chronic inflammatory demyelinating polyneuropathy (CIDP), primary humoral immunodeficiency disease (PIDD), and idiopathic thrombocytopenic purpura (ITP). “
Blood is big business,
“the Plasma Fractionation Market was valued at $16,573.4 Million in 2014 and expected to reach nearly $25,383.4 Million by 2019.”
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