Impax launches new high-strength ADHD generics

Generics/News | Posted 11/08/2017 post-comment0 Post your comment

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).

88 MD002468

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].

Related articles
FDA approval for generics of ADHD drug Strattera

Endo accused of Opana pay-for-delay

References
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: Impax

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010