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Kaletra Tablet Pediatric Formula Filing in Thailand
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Abbott press release
Abbott will file the pediatric formulation of Kaletra Tablets in Thailand, pending acceptance by the Thai government.
As with all developing world countries, Abbott is pursuing registration of the tablet as quickly as possible where HIV is prevalent, Brazil, India, China and Africa, etc. Abbott will submit their applications however, it is up to governments to accept the filings and to provide access to patients.
Filing around the world is a top priority for Abbott, and are happening now. Approval timelines are ultimately up to governments.
This is about providing children who have HIV/AIDS a life saving medicine where no generic are available yet. One of the few alternative PI therapies for children was just recalled globally from the market due to manufacturing contamination. Therefore, Abbott is being pragmatic about this.
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