Glenmark gets USFDA nod for amphetamine sulfate tablets to treat ADHD
Mumbai: Pharma major, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg,
The product is a 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 $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.
Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.