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ADHD generic receives US FDA approval Posted 23/10/2015

US generics maker Impax Laboratories (Impax) announced on 21 October 2015 that the company had received approval for its attention deficit hyperactivity disorder (ADHD) guanfacine generic.

The product is a generic version of Shire Pharmaceutical’s (Shire) Intuniv (guanfacine) and Impax has gained approval for dosages of 1, 2, 3 and 4 mg of the extended-release tablets for the US market.

Guanfacine is a non-stimulant medication for the treatment of ADHD that can be used alone, or as an add-on to stimulant medications. Shire’s patent for Intuniv expired in September 2015.

The news comes following resolution of Impax’s warning letter from the US Food and Drug Administration (FDA), which the company received back in 2011. The warning letter was issued due to ‘significant violations of Current Good Manufacturing Practice (CGMP) regulations’, which included lack of written procedures for manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and drug product and failure to investigate batch failures.

Impax announced on 8 September that it had successfully addressed all items raised by FDA in the May 2011 Warning Letter relating to its Hayward, California manufacturing facility. This followed a reinspection in 2015 by FDA of the Hayward facility.

In the last five weeks, since the resolution of the warning letter at the Hayward facility, FDA has approved three Impax generics from this site.

According to IMS Health, brand and generic sales of guanfacine extended-release tablets in dosages of 1, 2, 3 and 4 mg in the US were approximately US$689 million for the 12 months ending in August 2015.

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Source: US FDA, Impax

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