|
Back
to Product News Main Page
New Power for Electrosurgery
After receiving premarket notifi-cation in 2005 from the US Food and Drug Administration (FDA), Valleylab recently unveiled a new energy platform (ForceTriad) for use in both electrosurgery and tissue fusion. The new electrosurgical generator combines various capabilities in one platform, serving as a single, integrated energy system in
the operating room. Improved
tissue-sensing and closed-loop
control provides energy precision for electrosurgical cutting and coagulation for open and laparoscopic procedures.
back to top
Easing Hot Flashes
The FDA recently announced the approval of BioSante Pharmaceuticals, Inc’s transdermal
estradiol gel (Bio-E-Gel [Elestrin]) for the treatment of moderate-
to-severe vasomotor symptoms in menopausal women. Bioidentical to endogenous estradiol estrogen, the fast-drying, topical gel is available in daily dosages of 0.87 and 1.7 g. BioSante’s estradiol gel 0.87 g daily formulation offers patients efficacy at the lowest FDA-approved dose of estradiol currently available.
back to top
New Indication for
Breast Cancer Drug
The FDA recently approved Genentech, Inc’s application
for the expanded use of trastuzumab (Herceptin), in combination with doxorubicin, cyclophosphamide, and paclitaxel, for the treatment of
human epidermal growth
factor receptor-2 positive
(HER-2+), node-positive breast cancer. Administered intravenously, the monoclonal antibody binds to the overactive HER-2 protein that causes the overgrowth of cancer cells in the breast.
back to top
New Developments
for Depression
After receiving a citizen petition
for formal action, the FDA granted approval to Anchen Pharmaceuticals
Inc’s request to manufacture the first generic version of GlaxoSmithKline’s
bupropion hydrochloride (Wellbutrin XL).
The availability of generic 150- and 300-mg bupropion hydrochloride
extended-release tablets reflects the FDA’s commitment to increasing
the availability of low-cost generic drugs to the public.
back to top
|
