FDA generic approvals reached a record high in fiscal year 2019

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FDA generic approvals reached a record high in fiscal year 2019

By Sandra Levy - 10/22/2019

In 2018, competition from generic drugs saved the health care system about $293 billion. So said Food and Drug Administration acting commissioner Norman "Ned" Sharpless in a statement outlining the progress that has been made in providing patients with access to effective and high-quality generic drugs.

“Thanks to the FDA’s ongoing efforts under the Drug Competition Action Plan and the Generic Drug User Fee Amendments, the FDA has built a thriving generic drug program that continues to impress me. I am pleased to report that our generic drug program is having another strong year. While we expect to see highs and lows in our approval numbers from month to month based in part on what is submitted to us for assessment, I’m delighted to share that our fiscal year 2019 figures overall show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals),” said Sharpless.

Sharpless continued, “This breaks our all-time record of 971 for fiscal year 2018. Additionally, in fiscal year 2019 we approved 125 applications for first generics of medicines that had no generic competition. First generics approved in fiscal year 2019 included an emergency opioid overdose treatment and drugs to treat conditions such as pulmonary arterial hypertension, breast cancer, seizures, depression and various infections. Also, of note, the FDA is approving increasing numbers of complex generic drugs, which are harder to copy and traditionally have lacked competition."

In the coming months, the FDA plans to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers. "We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines," Sharpless said.

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