New Delhi: Drug firm Zydus Cadila said it has received final approval from the US health regulator to market anti-diuretic Desmopressin nasal spray solution in the American market.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Desmopressin nasal spray solution USP, 10 mcg/0.1 mL per spray, 5 ml bottle, Zydus Cadila said in a statement.
The product will be manufactured at the group’s formulations manufacturing facility at Moraiya in Ahmedabad, it added.
The nasal spray is indicated as an anti-diuretic replacement therapy in the management of central diabetes insipidus, excessive urination and drinking excessive amounts of fluids following head trauma or surgery in the pituitary region and nocturia, Zydus Cadila said.
The group now has more than 160 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process by the company.