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FDA approved over 1,000 generic drugs in 2019

Published on 20/02/20 at 10:23am

The FDA covered a lot of ground in 2019 when it came to generic drugs, awarding at least tentative approval to over 1,000 such products over the course of the year.

The achievement was confirmed with the release of the 2019 Annual Report of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) of the FDA.

According to the report, the US regulator approved, either tentatively or otherwise, 1,014 Abbreviated New Drug Applications (ANDAs) for generic drugs over the course of 2019; 107 of these were the first generic therapies of their type.

Tentative approvals however do not allow an applicant to actually sell its drug product on the market until all patent and exclusivity issues are resolved. In terms of purely final approvals, the agency awarded authorisation to 830 products, a climbdown from its record-breaking year in 2018 when it approved 971 generic drugs.

“This year, our approvals included 110 complex generic drugs – which are harder to develop and traditionally have lacked competition – and 107 applications for first generics of medicines that had no generic competition, including drugs to treat pulmonary arterial hypertension, breast cancer, seizures, depression, and various infections,” explained Dr Sally Choe, Director at the Office of Generic Drugs.

“OGD also continued efforts under FDA’s Drug Competition Action Plan (DCAP) and the Generic Drug User Fee Amendments (GDUFA) programme to improve upon efficiencies in generic drug development, increase timeliness in assessment processes, provide more clarity in the science and regulation of complex generic drugs, and close loopholes that may allow delays in generic drug competition,” she continued. 

“In the coming year, we’ll continue to take important steps to assist generic drug applicants with developing high-quality applications. We will also conduct more conferences and workshops on generic drug development to further engage with stakeholders and generic drug developers. In 2020, we will continue to do all that we can to increase access to generic medicines.”

Matt Fellows

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