Easier Access to Affordable Generic Medicines
This act aims to facilitate the market entry of more affordable generic drugs, even if the original drug's labeling was recently updated. This could allow citizens quicker access to cheaper medication alternatives, potentially lowering healthcare costs.
Key points
Speeds up approval for generic drugs, even if the brand-name drug's labeling was recently changed before patent expiration.
Generic drugs can be approved with temporary labeling differences from the brand-name drug, provided warnings section is unchanged.
Generic drug manufacturers will have 60 days to update their labeling after approval.
Expired
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