Netherlands-incorporated Mylan (Nasdaq: MYL) says that it expects to be the first to launch, upon regulatory approval and for developing country markets funded by international donors, TLE400 (tenofovir disoproxyl fumarate 300mg + lamivudine 300mg + efavirenz 400mg) for $99 per patient, per year.
Mylan partnered with the Clinton Health Access Initiative (CHAI) to develop TLE400. The significantly reduced price could generate savings of tens of millions of dollars for national AIDS programs that aim to double the 15 million people on antiretroviral (ARV) treatment in developing countries. Mylan expects to file a New Drug Application for TLE400 with the US Food and Drug Administration in the first quarter of 2016.
TLE400 included in WHO ARV guidelines
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