Today, the Food and Drug Administration published its 2018 Office of Generic Drugs Annual Report.
The report includes the approval or tentative approval of more than 1,000 generic drugs, with record-breaking monthly approval actions in October and November. First generics (approvals for generic drug products for branded drugs that previously had no FDA-approved generic) made up nearly 10 percent of the approvals in 2018 and about 14 percent of approvals were for complex generic drug products.
GDUFA II bridging activities for older generic drug applications and Abbreviated New Drug Applications (ANDAs) helped us achieve this high level of productivity, which resulted in the largest number of regulatory actions in a single year. Now, all ANDAs have review goals, regardless of when the application was originally submitted to FDA. We also implemented a new statutory pathway for designating drugs as Competitive Generic Therapies (CGTs), and five new ANDAs for generic drug products designated as CGTs were approved and granted CGT exclusivity per the FDA Reauthorization Act of 2017.
The report released today demonstrates how the FDA’s work with industry, the research community, physicians, health care providers, lawmakers, and other stakeholders is helping to make high quality, affordable generic drugs available for the benefit of the American public.
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