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Impax launches new high-strength ADHD generics Posted 11/08/2017

Impax Laboratories Inc (Impax) has received US Food and Drug Administration (FDA) approval for additional strength capsules of generic Focalin XR (dexmethylphenidate hydrochloride), which was originally marketed by Novartis and is used to treat attention deficit hyperactivity disorder (ADHD).

ADHD is estimated to affect over 51 million people, making drugs for the neurodevelopmental condition big business for the pharmaceutical industry.

Dexmethylphenidate hydrochloride extended-release capsules, originally marketed as Focalin XR, are indicated for treatment of ADHD in children aged six or above.

Impax is a US-based specialty pharmaceuticals firm specializing in central nervous system (CNS) agents, which markets both generic and branded drug products. The company announced in May 2017 that it received FDA approval for generic versions of Focalin XR extended-release capsules in two doses (25 mg and 35 mg); and immediately launched the drugs onto the market.

The company had already commercialized generic Focalin XR in five lower strength doses (5 mg, 10 mg, 15 mg, 20 mg and 30 mg) and first received FDA approval for the drug back in 2015 [1].

This could generate significant additional revenue for the company as the two new dosages of Focalin XR generated US sales of over US$90 million over the previous year, according to IMS Health. This follows other good news for the company, which recently received approval for a generic version of anti-cholesterol drug Vytorin [2].

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1. GaBI Online - Generics and Biosimilars Initiative. ADHD generic receives US FDA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Generics/News/ADHD-generic-receives-US-FDA-approval
2. GaBI Online - Generics and Biosimilars Initiative. Vytorin generic launched in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Generics/News/Vytorin-generic-launched-in-the-US

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Source: Impax

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