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news.The US Food and Drug Administration (FDA) has accepted EffRx Pharmaceuticals' EX101 new drug application (NDA).
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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 .