Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg, the therapeutic equivalent of DDAVP, 0.1 mg and 0.2 mg, of Ferring Pharmaceuticals, Inc. Glenmark plans to commence shipping of Desmopressin Acetate Tablets immediately.
The DDAVP market achieved annual sales of approximately $72.1 million, according to IMS Health sales data for the 12 month period ending March 2015.
Glenmark’s current portfolio consists of 97 products authorized for distribution in the US marketplace and 68 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.