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USFDA approves Glenmark’s investigational new drug application

The US health regulator has cleared Glenmark‘s investigational new drug (IND) application to begin a phase two study of GSP 304 to be used in treating respiratory disease.

Glenmark has said in a BSE filing that “The US Food and Drug Administration (FDA) cleared the company’s investigational new drug (IND) application to begin a phase two study of GSP 304 (tiotropium bromide) for administration by nebulisation for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic onstructive pulmonary disease (COPD).”

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