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FDA In Brief: FDA highlights record-breaking number of generic drug approvals in October

November 9, 2018

Media Inquiries

  Lyndsay Meyer
  240-402-5345

“The FDA plays an important role in approving high-quality medicines and promoting more generic drug competition. Over the past two consecutive years, the agency approved record numbers of generic drugs. Now we’re beginning the new fiscal year by breaking another record, this time with the highest number of approved or tentatively approved generics ever in a month,” said FDA Commissioner Scott Gottlieb, M.D. “Through our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled. And perhaps even more importantly, our efforts are having a real impact on reducing the number of review cycles of generic drug applications, making the process more efficient overall so that we can dedicate our resources to getting quality generic medicines to Americans sooner. We’ll continue our efforts to increase competition and help lower costs for patients with our Drug Competition Action Plan and will do so by continuing to advance policies that increase the efficiency of our generic drug program and working to approve high quality generic medicines that meet our standards..”

Today, the U.S. Food and Drug Administration is providing a summary of the generic drug approval actions for the month of October 2018 as part of its efforts to improve patient access to high-quality, lower cost, safe and effective medicines.

In October, the FDA approved 110 generic drugs and tentatively approved 18 generic drugs, for a total of 128 approval actions. This included 23 first generics for brands that lacked competition and 17 complex generics.

In October, the FDA also issued a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS). The increased transparency and predictability provided by these recommendations gives applicants seeking FDA approval of generic versions of these complex products a better understanding on how to efficiently and successfully develop these products, and prepare better and more complete applications. The FDA also issued 25 related product-specific guidance documents to provide recommendations for applications for such complex products. Of these, 23 were revised to update newer scientific understanding and 2 were new guidances. These documents help assist industry in identifying appropriate science-based methodologies and critical evidence for development and approval of generic TDS products.

Promoting more generic competition to complex medicines – is a key part of the FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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