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Zydus Cadila gets USFDA nod to market Risedronate drug to treat osteoporosis


Zydus Cadila gets USFDA nod to market Risedronate drug to treat osteoporosis
Risedronate tablets are used to treat Paget’s disease of bone. Risedronate is in a class of medications called bisphosphonates. Risedronate alters bone formation and breakdown in the body.
New Delhi: Drug firm Zydus Cadila has recently 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. Cadila Healthcare is an Indian pharmaceutical company headquartered at Ahmedabad in Gujarat state of western India.
The product will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, it added.Osteoporosis involves a gradual weakening of the bones. “Osteoporosis” literally means “porous bones.” The bones become weaker, increasing the risk of fractures, especially in the hip, spinal vertebrae, and wrist. Bone tissue is constantly being renewed, and new bone replaces old, damaged bone. 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.



Source: with agency inputs
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