Pharmaceutical Business review

FDA accepts EffRx Pharma EX101 NDA

EX101 is a proprietary buffered effervescent dosage form of alendronate sodium administered once weekly.

It is indicated to treat osteoporosis in postmenopausal women and increase bone mass in men with osteoporosis.

Currently, the company is in the process of securing partnership for distribution of EX101 in the US and Japan.

EffRx Pharmaceuticals, a Switzerland-based privately held drug delivery technology company, has licensed commercialization of EX101 to Nycomed in the rest of the world .