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FDA Mediation Watch: All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall – Lack Of Sterility Assurance

By fdanews on Sunday, May 19th, 2013 | No Comments

If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection. MedWatch Safety Alert RSS Feed

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FDA Press Releases: FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

By fdanews on Sunday, May 19th, 2013 | No Comments

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients. Food and Drug Administration–Press Releases

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FDA Mediation Watch: Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches

By fdanews on Thursday, May 16th, 2013 | No Comments

Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. MedWatch Safety Alert RSS Feed

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FDA Press Releases: FDA approves new drug for advanced prostate cancer

By fdanews on Wednesday, May 15th, 2013 | No Comments

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. Food and Drug Administration–Press [...]

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FDA New Drugs Feed: FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use

By fdanews on Tuesday, May 14th, 2013 | No Comments

The U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. What’s New: Drugs RSS Feed

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