Glenmark's Generic Pradaxa Capsules Gets US FDA Tentative Approval

Glenmark Pharmaceuticals, USA has received the United States Food & Drug Administration (FDA) tentative approval for dabigatran etexilate capsules, 75 mg, 110 mg and 150 mg, the generic version of Pradaxa capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals.

According to IMS Health sales data for the 12 month period ending February 2017, the Pradaxa capsules, 75 mg, 110 mg and 150 mg market achieved annual sales of approximately usd 913 million.

Glenmark's current portfolio consists of 114 products authorized for distribution in the US marketplace and 65 ANDA's pending approval with the US FDA. 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.