|US FDA Approves Aspen Pharmacare's Fixed-Dose Combination Antiretroviral (3TC+AZT+Nevirapine)
|Clinical Trial Shows Safety and Effectiveness of 3-in-1 Antiretroviral
|May 16th Announcement by DHHS of Rapid Process for Review of Fixed Dose Combination and Co-Packaged Products
...There are two central and interrelated benefits that arise from the use of FDCs in the administration of Highly Active Antiretroviral Therapy (HAART) in developing countries. The first is a lower overall pill count that predictably increases adherence to treatment regimes. The second is that FDCs have been shown to increase compliance because patients can take all their required medicines on a regular and fixed schedule rather than having to cope with a more complicated schedule of multiple pills on differing time schedules. The impact of reduced pill count and of simplified dosing schedules is to decrease the incidence of resistance of the AIDS virus to ARV treatment.
|Pharmaceutical Industry Documents
|World Health Organization Documents
WHO encourages the use of fixed-dose combinations when formulations of assured quality and proven bioequivalence are available and offer operational advantages... WHO operates a voluntary prequalification system, in which, as of 1 December 2003, three manufacturers prequalified ZDV/3TC combinations, two prequalified d4T/3TC/NVP combinations, and one prequalified ZDV/3TC/ABC. The list of WHO-prequalified manufacturers is continuously updated and is available at: http://www.who.int/medicines
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