Lupin gets USFDA nod to market skin lotion
Drug firm Lupin on Monday said it has received final approval from the US health regulator to market its Fluocinonide topical solution used for the treatment of various skin conditions.
The company has received final approval to market generic Fluocinonide Topical Solution USP, 0.05 per cent from the United States Food and Drug Administration (USFDA), Lupin said in a statement.
The product is a generic version of County Line Pharmaceuticals LLC's Fluocinonide Topical Solution USP, in the same strength, it added.
As per IMS MAT March 2017 data, Fluocinonide Topical Solution USP, 0.05 per cent had US sales of $32.4 million, Lupin said.
The product is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses, it added.
The company's cumulative filings with the USFDA now stand at 368. It has received approvals for 219 products while 149 filings are pending approval.