Glenmark gets tentative US approval for Mylan’s acne cream

Glenmark Pharmaceuticals said it received tentative approval from the United States Food & Drug Administration for a generic version of Mylan Pharma’s acne cream Evoclin.

According to IQVIATM sales data, the EVOCLIN Foam 1% has sales of $17.0 million per year in the US.

EVOCLIN Foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.

Tentative approvals are given when the product still enjoys some protection or exclusivity under the law, which are expected to expire soon.

Any firm that has received tentative approvals can launch the product once the patents expire.

With the latest approval, Glenmark’s current portfolio consists of 156 products authorized for distribution in the U.S. and 59 generic approvals pending approval with the U.S. 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,” the company said.