Adverse Reactions, Generic Medicine and Labelling

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Adverse Reactions

Generic Medicine

Labelling

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

pharmaphorum

JUNE 3, 2021

The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its label that includes a claim of less weight gain with olanzapine on its own, a big problem with the widely-used generic drug that affects compliance with treatment.

Adverse Reactions

Adverse Reactions Labelling Generic Medicine

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

Quality Matters

OCTOBER 13, 2021

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.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Adverse Reactions Prescription Filling Compounding

Pharmacist Digest

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

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

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