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FDA publishes new draft guidance for ADHD generic Posted 24/11/2017

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

The new draft bioequivalence guidance document outlines the agency’s preferred design of bioequivalence studies to support abbreviated new drug applications (ANDAs). It recommends that two in vivo studies be carried out in both fasting and fed subjects. The guidance also recommends the dissolution test method and sampling times to be used and outlines where a waiver request for the in vivo testing can be made.

Draft guidance on methylphendiate hydrochloride
Date: October 2017

The originator drug Janssen Pharmaceutica’s attention deficit hyperactivity disorder (ADHD) drug Concerta (methylphenidate) was first approved in 1982.

ADHD is the most common neurobehavioural disorder diagnosed in children in the US. ADHD affects one in 10 US children and half of these children are diagnosed by the age of six. Globally, ADHD affects 3−5% of children, with 30−50% of those individuals diagnosed in childhood continuing to have symptoms into adulthood. Symptoms include problems paying attention and hyperactivity.

Back in 2014, FDA withdrew automatic substitution of two methylphenidate generics due to problems with release rate of the generics. The generics are intended to release the drug in the body over a period of 10 to 12 hours, but data showed that two of the generic versions may deliver the drug at a slower rate [1].

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1. GaBI Online - Generics and Biosimilars Initiative. FDA withdraws automatic substitution of two methylphenidate generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Generics/News/FDA-withdraws-automatic-substitution-of-two-methylphenidate-generics

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Source: US FDA

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