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

FDAToday, 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.

"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."

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.

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.

Most Popular Now

Novartis announces plan to initiate clinical trial…

Novartis today announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the effic...

Sanofi and Regeneron provide update on U.S. Phase …

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzar...

Gilead announces results from Phase 3 trial of inv…

Gilead Sciences, Inc. (Nasdaq: GILD) announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigation...

AstraZeneca and Oxford University announce landmar…

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine a...

Roche's COVID-19 antibody test receives FDA Emerge…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) (1) for its new Elecsys® Ant...

Pfizer and BioNTech dose first participants in the…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 va...

Frankfurt researchers discover potential targets f…

A team of biochemists and virologists at Goethe University and the Frankfurt University Hospital were able to observe how human cells change upon infection with SARS-CoV-...

Arthritis drug may improve respiratory function in…

A small study in Greece found that the clinically approved anti-inflammatory drug anakinra, used to treat rheumatoid arthritis, improved respiratory function in patients ...

Vitamin D linked to low virus death rate

A new study has found an association between low average levels of vitamin D and high numbers of COVID-19 cases and mortality rates across 20 European countries. The r...

Early indicators of vaccine efficacy

Ludwig-Maximilians-Universität (LMU) in Munich researchers have shown that a specific class of immune cells in the blood induced by vaccination is an earlier indicator of...

Loss of smell associated with milder clinical cour…

Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published ...

Can an existing HIV medication slow the spread of …

A team of scientists from St. Michael's Hospital, Sinai Health and Sunnybrook Health Sciences Centre have launched a clinical trial to understand whether an existing drug...