Glenmark receives final approval from USFDA for generic Vesanoid Capsules

27 Dec 2016 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Tretinoin Capsules, 10 mg, the generic version of Vesanoid Capsules, 10 mg, of Hoffmann La Roche, Inc. (which is no longer being marketed in the United States). 

According to IMS Health sales data for the 12 month period ending October 2016, the Vesanoid Capsules, 10 mg market achieved annual sales of approximately $22.0 million. 

Glenmark’s current portfolio consists of 112 products authorized for distribution in the US marketplace and 63 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. 


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