segunda-feira, janeiro 31, 2005
Aspen recebe aprovação da FDA para genéricos de AZT/3TC/NVP
Health Gap 27.01.05
Aspen Pharmacare announced yesterday the approval by the US FDA of a co-blistered combination of generic antiretrovirals (a blister pack containing co-formulating AZT and 3TC, co-packaged with a separate dose of nevirapine).
"This approval is too little, too late--and too unilateral," said BrookBaker of Health GAP, "The WHO already had an internationally supported Pre-Qualification Project for listing AIDS medicines of proven quality, including generic products." Since the launch of PEPFAR the Bush Administration has refused to permit PEPFAR grantees to procure more affordable generic medicines -- forcing them to waste limited resources on more costly brand name products, reaching fewer people with live saving medicines.
"Had affordable generic drugs been used by PEPFAR in the first place, more people may have been alive today," said Amanda Lugg of Health GAP.
According to several generic companies, some applications to the US approval process have been delayed because brand name drug companies are refusing to provide "reference rights" to the generic companies that would confirm the equivalence between European and US versions of originator products. As a result they are forced to redo their bioequivalence studies, wasting time and money. Aspen would have avoided this problem because of its existing cozy relationship with originator companies.
Aspen Pharmacare announced yesterday the approval by the US FDA of a co-blistered combination of generic antiretrovirals (a blister pack containing co-formulating AZT and 3TC, co-packaged with a separate dose of nevirapine).
"This approval is too little, too late--and too unilateral," said BrookBaker of Health GAP, "The WHO already had an internationally supported Pre-Qualification Project for listing AIDS medicines of proven quality, including generic products." Since the launch of PEPFAR the Bush Administration has refused to permit PEPFAR grantees to procure more affordable generic medicines -- forcing them to waste limited resources on more costly brand name products, reaching fewer people with live saving medicines.
"Had affordable generic drugs been used by PEPFAR in the first place, more people may have been alive today," said Amanda Lugg of Health GAP.
According to several generic companies, some applications to the US approval process have been delayed because brand name drug companies are refusing to provide "reference rights" to the generic companies that would confirm the equivalence between European and US versions of originator products. As a result they are forced to redo their bioequivalence studies, wasting time and money. Aspen would have avoided this problem because of its existing cozy relationship with originator companies.
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