Wikio - Food and Drug Administration

FDA approves Boston Scientific device for heart failure (The Minneapolis/St. Paul Business Journal)

Fri, 16 May 2008 20:42:46 GMT

The U.S. Food and Drug Administration has approved a device Boston Scientific Corp. has developed to help treat heart failure, the company announced Friday. (BSX)

Source : The Minneapolis/St. Paul Business Journal (subscribe)

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FDA stresses birth defect risks with Roche drug (San Fransisco Chronicle)

Fri, 16 May 2008 17:31:14 GMT

Health regulators reiterated their warning Friday that organ transplant drugs from Roche and Novartis can cause miscarriages and birth defects when used by pregnant women. The Food and Drug Administration previously said it received reports of miscarriages...

Source : San Fransisco Chronicle (subscribe)

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Boston Scientific heart failure treatment device gets FDA approval (The Boston Business Journal)

Fri, 16 May 2008 17:04:48 GMT

The U.S. Food and Drug Administration has approved a device Boston Scientific Corp. has developed to help treat heart failure, the company announced Friday. (BSX)

Source : The Boston Business Journal (subscribe)

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FDA Closes Contract Drug Manufacturer (Red Orbit )

Fri, 16 May 2008 17:00:36 GMT

The U.S. Food and Drug Administration said it obtained a permanent injunction preventing the production of drugs by Scientific Laboratories Inc.

Source : Red Orbit (subscribe)

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FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (Food and Drug Administration)

Fri, 16 May 2008 13:31:00 GMT

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain...

Source : Food and Drug Administration (subscribe)

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FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (Food and Drug Administration)

Fri, 16 May 2008 13:31:00 GMT

The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

Source : Food and Drug Administration (subscribe)

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Terguride Receives FDA Orphan Drug Designation For The Treatment Of Pulmonary Arterial Hypertension (Medical News Today)

Fri, 16 May 2008 11:00:00 GMT

Ergonex Pharma announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the treatment of pulmonary arterial hypertension (PAH). Terguride is currently being evaluated for PAH in a pivotal Phase II trial in Europe.

Source : Medical News Today (subscribe)

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Manufacturer Removes Remaining Stocks Of Trasylol (Medical News Today)

Fri, 16 May 2008 11:00:00 GMT

Background: On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding....

Source : Medical News Today (subscribe)

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FDA Approves Astrazeneca's Seroquel For Maintenance Treatment In Bipolar Disorder (Medical News Today)

Fri, 16 May 2008 09:00:00 GMT

AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL® (quetiapine fumarate) for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or divalproex.

Source : Medical News Today (subscribe)

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New Treatment For Hepatitis C: New Application For Drug Already Approved For Lowering Cholesterol (Medical News Today)

Fri, 16 May 2008 09:00:00 GMT

Researchers at the OU Health Sciences Center have found a new use for an old drug. Their findings appear online in the American Journal of Gastroenterology.The drug, Fluvastatin, has been approved since 1993 by the U.S. Food and Drug Administration for the treatment of elevated cholesterol in adults. Millions of patients have taken Fluvastatin for cholesterol without...

Source : Medical News Today (subscribe)

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Arpida Announces FDA Acceptance of the Iclaprim New Drug Application (Red Orbit )

Fri, 16 May 2008 08:00:32 GMT

REINACH, Switzerland, May 16 /PRNewswire-FirstCall/ -- Arpida Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections (cSSSI).

Source : Red Orbit (subscribe)

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St. Jude Medical Announces FDA And European CE Mark Approvals Of The IsoFlex Optim Pacing Lead (Medical News Today)

Fri, 16 May 2008 08:00:00 GMT

St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of the IsoFlex® Optim™ pacing lead. The small-diameter lead is built on the proven IsoFlex® pacing lead platform, and features the company's exclusive Optim® insulation material. With the addition of Optim insulation to IsoFlex leads, all St.

Source : Medical News Today (subscribe)

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FDA Takes Action against Cream Cheese Companies, Executives (ClearysNoteBook)

Fri, 16 May 2008 04:57:38 GMT

Media release May 16, 2008 Repeated federal violations and failure to correct drove action The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc....

Source : ClearysNoteBook (subscribe)

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FDA Takes Action against Cream Cheese Companies, Executives (Food and Drug Administration)

Thu, 15 May 2008 22:33:40 GMT

The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws.

Source : Food and Drug Administration (subscribe)

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Drug ad effects on people need more study: FDA (Reuters)

Thu, 15 May 2008 22:15:28 GMT

ROCKVILLE, Maryland (Reuters) - Ads for prescription drugs need to be clear and direct and government needs to study the effects these ads have on consumer behavior, particularly among the elderly and minorities, a U.S. Food and Drug Administration panel of outside experts said on Thursday.

Source : Reuters (subscribe)

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Drug ad effects on people need more study: FDA (Reuters UK)

Thu, 15 May 2008 22:15:28 GMT

Source : Reuters UK (subscribe)

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Bayer Withdraws Trasylol From U.S. Market (Red Orbit )

Thu, 15 May 2008 17:00:44 GMT

The U.S. Food and Drug Administration announced the Bayer Pharmaceuticals Corp. is removing its entire stock of the drug Trasylol from the U.S. market. Last November Bayer agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery.

Source : Red Orbit (subscribe)

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KV Pharmaceutical gets FDA approval for generic heart drug dosage (The St Louis Business Journal )

Thu, 15 May 2008 16:40:24 GMT

KV Pharmaceutical Co. announced Thursday that it received final approval from the U.S. Food and Drug Administration (FDA) to market its 50 mg strength of a generic version of hypertension and heart failure drug Toprol-XL, a branded product of drug maker AstraZeneca (NYSE: AZN). (AZN) (KV)

Source : The St Louis Business Journal (subscribe)

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St. Jude Medical Announces FDA Clearance and European CE Mark Approval for Tools That Help Place Leads in Challenging Heart Anatomy (Business Wire)

Thu, 15 May 2008 13:00:00 GMT

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of new delivery tools

Source : Business Wire (subscribe)

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Valeant Pharmaceuticals Announces FDA Has Initiated Reconsideration of Generic Efudex(R) Approval (Business Wire)

Thu, 15 May 2008 12:00:00 GMT

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Valeant Pharmaceuticals (NYSE:VRX) today announced that the Food and Drug Administration (the FDA) has entered an administrative order

Source : Business Wire (subscribe)

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