Produced by the US Food and Drug Administration (FDA)’s Office of Generic Drugs, the annual report highlighted its key achievements during 2018:
- Approved or tentatively approved 1,021 abbreviated new drug applications
- Published more than 250 new or revised guidances, product-specific guidances and manuals of policies and procedures for stakeholders
- Launched an online function for controlled correspondence inquiries from industry and responded to approximately 700 inquiries
- Issued 2,648 complete response letters detailing important issues to be resolved by the applicant before the FDA could grant an approval
First generics (approvals for generic drug products for branded drugs that previously had no FDA-approved generic) made up nearly 10% of the year’s approvals. Of these first generics, 18% were complex generic drugs and approximately 14% of all generics approvals were for complex generic drugs.
The office also implemented a new pre-abbreviated new drug applications program for complex generic drug products, which resulted in 92 meeting requests – double the amount of the previous year.
The FDA sponsored, co-sponsored and/or participated in seven regulatory science meetings and workshops focusing on complex generic drug development and generic drug user fee amendments.
‘Significant’ drug approvals noted by the FDA for the first generics of:
- Suboxone, treatment for opioid dependence
- EpiPen, emergency treatment for anaphylactic allergic reactions
- Zortress, preventative treatment for organ rejection
- Copaxone, treatment for multiple sclerosis
- Brilinta, treatment for heart diseases, strokes, and diabetes
Kathleen Uhl, director of the Office of Generic Drugs, said: “Our leadership is looking forward to challenges and opportunities in the years ahead. OGD’s critical role with industry, the research community, lawmakers, patients, health care providers, and other stakeholders in the United States and around the world will continue in order to safeguard access to affordable, high-quality generic drugs.”