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After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

pharmaphorum

The approval and favourable label should position Lybalvi for great success, as people taking antipsychotic medication for schizophrenia or manic episodes in bipolar disorder often list weight gain as one of the most common and debilitating adverse reactions to treatment.

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World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain

Quality Matters

With this extensive system in place, patients can trust that medicines with the same name will be consistent in quality no matter who manufactures it or where in the world it is made. Since manufacturers know the precise quality specifications, standards help make the approval process for generic medicines more efficient.