First Generics

24
Sep
First

First Generic Approvals for 2021 List Updated

The FDA has updated its first-generic approvals list for calendar year 2021 (here).  The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals.  As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]

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17
May

Office of Generic Drugs Updates First Generic Approvals List for 2019

Today, OGD updated its first generic approvals list (here).  So far this calendar year, OGD reports 43 first generic approvals through April 26, 2019.  The FDA notes: “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.  FDA considers […]

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