US FDA Nod for Generic Protopic

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%.

The United States Food & Drug Administration (FDA) has approved Tacrolimus Ointment, 0.03%, Glenmark Pharmaceuticals’ generic version of Protopic Ointment, 0.03%. 

Glenmark's Tacrolimus Ointment, 0.03%, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace and 51 ANDAs pending approval with the U.S. FDA. An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. 

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.