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FDA approves liquid form of Merck HIV drug Isentress for infants, small children
WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.
Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.
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FDA approves combination of two GSK drugs for skin cancer
SILVER SPRING, Md. — The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.
The FDA announced the new approval for Mekinist (trametinib) and Tafinlar (dabrafenib). The agency originally approved the two drugs for use as single agents for the same indication in May 2013.