Glenmark gets USFDA nod for Amphetamine Sulfate tablets

Glenmark gets USFDA nod for Amphetamine Sulfate tablets

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USFDA Approval
USFDA Approval

Last Updated on October 17, 2024 by The Health Master

Glenmark Pharmaceuticals Limited has received final approval by the United States Food & Drug Administration (USFDA) for amphetamine sulfate tablets USP, 5 mg and 10 mg, the generic version of Evekeo tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

According to IQVIA sales data for the 12 month period ending November 2020, the Evekeo tablets, 5 mg and 10 mg market achieved annual sales of approximately US$ 21.5 million.

Glenmark’s current portfolio consists of 168 products authorized for distribution in the US marketplace and 43 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.

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