- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- Senate passes Drug Quality and Security Act
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- Diplomat becomes distributor of recently approved cancer drug
- FDA advisory panel to consider OTC status of NSAIDs
FREIENBACH, Switzerland — The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.
EffRx Pharmaceuticals announced the FDA approval of Binosto (alendronate sodium), a strawberry-flavored tablet designed to dissolve in water that the company called the first treatment of its kind. The drug is designed to treat osteoporosis in menopausal women and increase bone mass in men with osteoporosis. EffRx expects to launch Binosto in third quarter 2012.
"Binosto is a breakthrough innovation for the treatment of osteoporosis, offering those patients that have difficulty with tablets the proven fracture risk reduction of alendronate in a pleasant-tasting and easy-to-swallow buffered solution," EffRx chairman and CEO Christer Rosen said.