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Hot Stock Movers On FDA’s Decision (MDT, CHTP, ACUR, AZN, MDCO)

Stocks On FDA’s Decision (MDT, CHTP, ACUR, AZN, MDCO)

(EMAILWIRE.COM, March 17, 2010 ) Dallas, Tx - Medtronic, Inc. (NYSE:MDT) fell 0.60% to $44.87 after hitting an intraday high of $45.24 after today announced it has completed Pre-Market Approval (PMA) submission in consideration for U.S. Food and Drug Administration (FDA) approval for the Medtronic Arctic Front Cardiac CryoAblation Catheter System, which is designed for patients with paroxysmal atrial fibrillation (PAF), an irregular quivering of the upper chambers of the heart that starts and stops on its own. Atrial fibrillation (AF) is the most common heart arrhythmia in the United States, with an estimated three million patients suffering from this condition.

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Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) fell 5.50% to $3.56 after it reported findings from Study 305, a study evaluating the effect of Northera (Droxidopa), an investigational agent being studied for the treatment of neurogenic orthostatic hypotension (NOH), on patients' 24-hour blood pressure (BP) profile.

Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) rose 4% to $5.66 after today it announced that the U.S. Food and Drug Administration ("FDA") has publically announced the scheduling of an April 22, 2010 Advisory Committee meeting to discuss the New Drug Application ("NDA") for Acurox (oxycodone HCl and niacin) Tablets and the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone.

AstraZeneca plc (ADR) (NYSE:AZN) and Bristol Myers Squibb Co. (NYSE:BMY) after today announced that the U.S. FDA has accepted for review a New Drug Application for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. Bristol-Myers Squibb and AstraZeneca submitted the NDA with the U.S. FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.

The Medicines Company (NASDAQ:MDCO) soared 21% to $10.00 after it announced today that it is voluntarily expanding the recall of Cleviprex (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials. Four (4) additional lots of Cleviprex are being recalled.

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