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First pregabalin generics approved by FDA Posted 18/10/2019

In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin) for the management of fibromyalgia, postherpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, and as adjunct therapy for partial-onset seizures in patients aged 17 years or over.

Over nine million people in the US have been prescribed Lyrica since its approval in 2005, according to its manufacturer Pfizer. It must be dispensed with a patient medication guide that contains information on the risks associated with the drug which include angioedema, serious allergic reactions, dizziness, sleepiness, and suicidal thoughts or actions. Commonly reported adverse reactions to Lyrica have included swelling, blurred vision, dry mouth and weight gain.

For generics to be approved, there must be evidence that they can be manufactured correctly and consistently, and that they have the same active ingredients, pharmaceutical equivalence, and biological and physiological results as the branded product. According to FDA, nine pharmaceutical companies in the US, India and Israel can now manufacture and market generic versions of pregabalin.

The approval of pregabalin generics came as part of a wider endeavour set forth by FDA’s Drug Competition Action Plan. Launched in June 2017, this plan aims to expand patient access to more affordable medicines by addressing the challenges related to developing generics and by promoting generics competition [1]. Because the studies needed to develop a generic drug typically require 1,500 to 3,000 doses of the brand-name version, FDA plans to address the anticompetitive practices that pharmaceutical companies use to restrict access to the brand-name drugs. FDA has proposed co-ordinating with the Federal Trade Commission to identify and publicise anticompetitive practices.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 18]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition

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Source: US FDA

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