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Sandoz Recall Losartan Lot Due to Impurity

[ Price : $8.95]

Sandoz recalls one lot of losartan potassium and hydrochlorothiazide after an impurity, NDEA (N-nitrosodiethylamine), was detected...

Record Generic Approvals Last Month

[ Price : $8.95]

FDA approves a record number of generic drugs in October as part of its efforts to improve patient access to lower cost drugs.

FDA Seizes Products Held Under Insanitary Conditions

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On FDAs orders, U.S. marshals seize FDA-regulated products that the agency says were being held under insanitary conditions that e...

FDA Illegally Regulates Some Devices as Drugs: Attorney

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Attorney Jeffrey Shapiro says FDA should seek congressional authority to continue to regulate some medical devices as drugs.

Vivozon Given Fast Track for Non-Opioid Pain Killer

[ Price : $8.95]

FDA has granted Korea-based Vivozon a fast track designation for VVZ-149, a non-opioid pain killer.

FDA Expanded Access Web Page Being Improved

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FDA says it is updating its Expanded Access Web pages and taking other steps to improve the program for patients and healthcare pr...

Cardiac Testing Still Needed for Diabetes Drugs: LaMattina

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Former Pfizer executive John LaMattina says FDA should consider ways to streamline cardiovascular outcome trials for diabetes drug...

New Monteris Medical NeuroBlate Probe Coming: FDA

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FDA says it has cleared a new Monteris Medical probe to replace one that was recalled due to unintended overheating in the magneti...

Axiron Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that Eli Lillys Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation...

Revive Therapeutics Orphan Status for Cannabidiol

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FDA grants Revive Therapeutics an orphan drug designation for cannabidiol for preventing ischemia and reperfusion injury resulting...