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Drug firm Zydus Cadila has received a final nod from the US health regulator for Risedronate Sodium delayed-release tablets, used for the treatment of osteoporosis in postmenopausal women.
The company has received final approval from the USFDA to market the tablets in the strength of 35 mg in America, Zydus Cadila said in a statement on Thursday. The product will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, it added.
Risedronate alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures. This medicine is used to treat osteoporosis in women, caused by menopause, Zydus Cadila said.
The group now has 218 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.
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