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US FDA Approves 30-Minute Onset of Action for Focalin(R) XR, Bringing Potential Benefits to ADHD Patients During Early Morning Period
Date:11/12/2008

seizures or EEG abnormalities. Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. (See WARNINGS.)

Focalin XR should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Please see full Prescribing Information for Focalin XR including Contraindications, Boxed Warning and Medication Guide at http://www.FocalinXR.com or call us at 1-888-NOW-NOVA.

For further information, please visit http://www.FocalinXR.com.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "potential," "may," "potentially," "can," or similar expressions, or by express or implied discussions regarding potential additional labeling or indications or potential future sales of Focalin XR. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Focalin XR will be approved for any additional labeling or indications in any country. Nor can there be any guarantee that Focalin XR will reach any particular sales levels. In particular, management's expectations regarding Focalin XR
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SOURCE Novartis Pharmaceuticals Corporation
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