EU CHMP recommends approval of Daptomycin Hospira (daptomycin), a generic form of Cubicin, for infections- Hospira
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Daptomycin Hospira (daptomycin), from Hospira, intended for the treatment of complicated skin and soft tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to Staphylococcus aureus and S. aureus bacteraemia associated with RIE or with cSSTI.
Daptomycin Hospira will be available as a powder for solution for injection/infusion (350 mg and 500 mg). Daptomycin Hospira is a generic of Cubicin, which has been authorised in the EU since 19 January 2006. Studies have demonstrated the satisfactory quality of Daptomycin Hospira. Since Daptomycin Hospira is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product was not required.
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