FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

OGD Reports Continued Increase in First-Time Generic Approvals in 2018

March 7, 2019

The FDA’s Office of Generic Drugs released its annual report for 2018, highlighting a steady increase in first-time generic approvals and the green lighting of more than 1,000 generic drugs.

OGD’s outgoing Director Kathleen Uhl — who retired in February after two decades with the agency — called 2018 “an extremely successful year,” noting that the agency approved or tentatively approved a total of 1,021 ANDAs, with first generics accounting for approximately 10 percent and complex generics comprising roughly 14 percent.

The office approved 88 first-time generics for the year, compared to 80 the previous year and 73 in 2016. Significant 2018 approvals included first-time generics for Suboxone (buprenorphine and naloxone), Zortress (everolimus) and EpiPen (epinephrine).

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