Actavis Receives FDA Approval Of Atomoxetine HCl Capsules
Main Category: ADHDAlso Included In: Regulatory Affairs / Drug Approvals; Pharma Industry / Biotech Industry
Article Date: 02 Sep 2010 - 2:00 PDT
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Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD).
Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths. No release date for Atomoxetine, Actavis' generic equivalent to Eli Lilly and Company's Strattera®, has been set. The U.S. Court of Appeals for the Federal Circuit is reviewing an Aug. 12 ruling that invalidated Lilly's patent, which is due to expire in 2017.
U.S. sales of Strattera® totaled $532 million for the 12-month period ended June 2010, according to IMS Health data.
Any statements contained in this press release that refer to Actavis' estimated or anticipated future results or future activities are forward-looking statements which reflect the Company's current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors.
Source: Actavis Inc
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MLA
12 Feb. 2012. <http://www.medicalnewstoday.com/releases/199692.php>
APA
http://www.medicalnewstoday.com/releases/199692.php.
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Visitor Opinions In Chronological Order (2)
oxetines are oxetines
posted by Terry Walker on 3 Sep 2010 at 5:52 amduloxetine (cymbalta); fluoxetine (prozac); paroxetine (paxil)-dapoxetine was not approved because of its potential side effects; atomoxetine!
T. Walker -- Totally wrong.
posted by L Gilbert on 15 Jan 2011 at 1:39 amFluoxetine has been in generic for ten years.
Paroxetine went generic not long afterwards.
Duloxetine (Cymbalta) is still under patent; it has nothing to do with side effects.
Dapoxetine (Priligy) isn't currently approved in the US but is in phase III trials.
These, and atomoxetine are all indicated for different things. There may be *some* overlap but atomoxetine isn't even an SSRI like the others. It's an SNRI. Suggesting "Oxetines are oxetines" is incredibly incorrect/ignorant.
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