Glenmark Pharmaceuticals today said it has received the final approval from US health regulator for its generic version of Desmopressin Acetate tablets used in the treatment of diabetes and bed-wetting.
The approval by the US Food and Drug Administration (USFDA) is for strengths of 0.1 mg and 0.2 mg and the company plans to immediately begin shipments to the US, Glenmark said in a statement.
Desmopressin Acetate is sold under the trademark DDAVP by Ferring Pharmaceuticals. Citing IMS data, Glenmark said: “DDAVP market achieved annual sales of approximately $72.1 million in the 12 month period ended March 2015.’’
Glenmark’s current portfolio consists of 97 products authorised for distribution in the US and 68 abbreviated new drug approvals with the USFDA.
Shares of Glenmark Pharmaceuticals were trading at Rs. 872 per scrip in afternoon trade, up 1.71 per cent from the previous close on the BSE. PTI
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