Switzerland’s Vifor Pharma is celebrating after getting the thumbs-up from US regulators for Injectafer for the treatment of iron deficiency anaemia.
The US Food and Drug Administration has approved the treatment, sold in Europe as Ferinject (ferric carboxymaltose) since getting the green light in 2007. Specifically, Injectafer will be available for the treatment of IDA in adults who have had an unsatisfactory response or are intolerant to oral iron.
The approval is based on two large trials conducted by Vifor’s US partner Luitpold Pharmaceuticals which studied more than 3,500 patients, of which 1,800 were treated with Injectafer.
read all at
http://www.pharmatimes.com/Article/13-07-26/Vifor_gets_FDA_approval_for_Injectafer.aspx
Ferric carboxymaltose
Chemical structure
The active substance of FERINJECT is a complex of polynuclear iron(III)-hydroxide with 4(R)-(poly-(1→4)-
O-α-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. The relative molecular weight is
approximately 150,000 Da, corresponding to the empirical formula:
[FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k, where n ≈ 103, m ≈ 8, l ≈ 11, and k ≈ 4.
CAS-Number
9007-72-1
http://www.tga.gov.au/pdf/auspar/auspar-ferric.pdf for structure
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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