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2019 saw the FDA approve more generic drugs than ever before

Published on 18/10/19 at 10:23am

Fiscal year 2019 was a record-breaking one, according to the FDA. The US regulator smashed its previous total for annual generic drug approvals with 1,171 positive reviews completed that year, comprising 935 approvals and 236 tentative approvals.

Furthermore, of this total, 125 approvals were the first generic versions of their respective reference products, meaning there was no previous generic competition prior to the FDA’s ruling. This included treatments for pulmonary arterial hypertension, breast cancer, depression, seizures, infectious diseases, and even an emergency opioid therapy.

This latest total eclipses the previous record of 971 generic approvals, set just last year, and is emblematic of the agency’s drive to push for greater pharmaceutical competition through increased access to generic therapies; this, in theory, should bring down costs for patients. According to the FDA, 90% of all US prescription drug purchases are for generics, and competition from these drugs generated around $293 billion in cost savings across the nation’s healthcare system.

“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 programme that continues to impress me,” Acting FDA Commissioner Ned Sharpless commented on the achievement. “I am pleased to report that our generic drug programme 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.”

He added: “The FDA’s scientific review and assessment process for generic drug applications ensures that generic medications perform the same way in the human body, have the same active ingredients and have the same conditions of use as their counterpart name-brand medication.”

Matt Fellows

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