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Mylan Receives Tentative Approval for "TLD" Under PEPFAR

Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDS

TLD is comprised of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg

HERTFORDSHIRE, England and PITTSBURGH, Aug. 7, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg (TDF-3TC-DTG or "TLD"). TLD, an antiretroviral (ARV) fixed-dose combination, will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS. Mylan's TLD combines molecules from three originator medicines - ViiV Healthcare's Tivicay® (via a license through the...


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