A U.S. advisory panel on Thursday recommended approval of Egalet Corp’s long-acting opioid painkiller, Arymo ER, saying it dulls pain and could deter abuse by addicts seeking a quick high. The panel recommended that the Food and Drug Administration (FAD) approve the drug and said it deters, but does not eliminate, the risk of abuse…
FDA Panel Backs Valeant Psoriasis Drug with Risk Program
Valeant Pharmaceuticals International Inc’s experimental drug to treat the skin disorder psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory…
FDA panel to vote whether diabetes drug cuts cardiac death
An advisory panel to the U.S. Food and Drug Administration will be asked to vote next week on whether a diabetes drug made by Eli Lilly & Co and Boehringer Ingelheim cuts the risk of cardiovascular death, according to documents posted on the agency’s website on Friday. The documents were published ahead of a June…