Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets USP, 5 mg, 10 mg

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo 1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

According to IQVIATM sales data for the 12 month period ending November 2020, the Evekeo Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately USD 21.5 million.

Glenmark's current portfolio consists of 168 products authorized for distribution in the U.S. marketplace and 43 ANDA's 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.

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( With inputs from ANI )