14.04.2011
Ortho-McNeil Recalls Topamax 100-mg Tablets
BETHESDA, MD 14 April 2011—Ortho-McNeil Neurologics this morning announced a recall of lots 0KG110 and 0LG222 of Topamax 100-mg tablets because consumers have complained... |
|
14.04.2011
Olmesartan`s Benefits in Treating Hypertension Outweigh Potential Risks, FDA Says
BETHESDA, MD 14 April 2011—FDA, after reviewing the results of placebo-controlled studies that found higher rates of cardiovascular-related death in patients with type 2... |
|
08.04.2011
FDA Approves Gabapentin Prodrug as Restless Legs Treatment
BETHESDA, MD 08 April 2011—XenoPort Inc. and GlaxoSmithKline on Wednesday announced that FDA approved the companies` gabapentin enacarbil product, Horizant, for the... |
|
01.04.2011
Alabama Pharmacy`s TPN Linked to Nine Deaths
BETHESDA, MD 01 April 2011— FDA and the Alabama Department of Public Health (PDF) on Wednesday announced an outbreak of Serratia marcescens bacteremia in six Alabama... |
|
25.03.2011
FDA Eases Medication Guide Distribution Requirements
BETHESDA, MD 25 March 2011—A draft guidance document from FDA relaxes the agency`s stance on the need to distribute medication guides to inpatients. According to the... |
|
22.03.2011
Correction Notice for `AHFS Drug Information` Bivalirudin Monograph
BETHESDA, MD 22 March 2011—Users of AHFS Drug Information® (AHFS DI®) should be aware of a correction to the monograph on bivalirudin. The error resulted from an... |
|
17.03.2011
Embeda Capsules Recalled
BETHESDA, MD 17 March 2011—Pfizer subsidiary King Pharmaceuticals has recalled all Embeda morphine sulfate–naltrexone hydrochloride extended-release capsules, the... |
|
15.03.2011
FDA Approves New Imaging Agent
BETHESDA, MD 15 March 2011— FDA and Bayer HealthCare Pharmaceuticals today announced the approval of gadobutrol injection, or Gadavist, a macrocyclic gadolinium-based... |
|
14.03.2011
FDA Seeks Advice on Track-and-Trace Systems
SILVER SPRING, MD 14 March 2011—A February 15–16 FDA public workshop on track-and-trace systems for prescription drugs drew more than 100 registrants, and agency... |
|
11.03.2011
FDA`s First Active Medical Product Surveillance Eyes Antidiabetic-MI Link
BETHESDA, MD 11 March 2011—By the end of March, the first data analysis based on FDA’s fledgling electronic active surveillance system for medical products should be... |
|
