FDA Actions in Brief April 2012


Recent FDA Approvals (through April 2012) related to (Johnson & Johnson, AstraZeneca, Affymax, Takeda Pharmaceutical, Teva Pharmaceutical Industries, Avioq, Hope Pharmaceuticals, Novo Nordisk, Avid Radiopharmaceuticals)

Etravirine (Intelence, Johnson & Johnson) was approved for the treatment of HIV-1 in children aged 6 years to younger than 18 years who have taken other therapies but whose infection has become resistant to treatment.

Metoprolol succinate extended release/hydrochlorothiazide (Dutoprol, AstraZeneca) tablets, the first and only once-daily antihypertensive agent that contains the active ingredient of Toprol-XL (metoprolol succinate) plus a low-dose diuretic for the treatment of high blood pressure.

Peginesatide (Omontys, Affymax and Takeda Pharmaceutical) was approved for the treatment of anemia in adult dialysis patients who have chronic kidney disease.

Test (Avioq HTLV-I/II Microelisa System, Avioq) was approved to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases was approved.

Sodium Nitrite Injection (Hope Pharmaceuticals) for sequential use with sodium thiosulfate for the treatment of cyanide poisoning that is judged to be life-threatening.

Insulin detemir [rDNA origin] (Levemir, Novo Nordisk) was approved for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses.

Florbetapir F 18 Injection (Amyvid, Avid Radiopharmaceuticals) was approved for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's and other causes of cognitive decline.

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