Glenmark Gets U.S. FDA’s Final Approval For Deferasirox Tablets
Glenmark Pharmaceuticals Ltd. has received the final approval from the U.S. health regulator for Deferasirox tablets for oral suspension, the Mumbai-based drugmaker said on Tuesday.
"Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg, the generic version of Exjade1 tablets for oral suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation," the company said in a filing to the Bombay Stock Exchange.
Deferasirox tablets are used to treat high levels of iron in the body caused by multiple blood transfusions.
According to IQVIA sales data for the 12-month period ending November 2019, exjade tablets for oral suspension—125 mg, 250 mg and 500 mg—had annual sales of about $106.4 million, or about Rs 750 crore.
Glenmark's current portfolio consists of 165 products authorised for distribution in the U.S. and 43 abbreviated new drug applications, or ANDAs, are pending approval with the U.S. FDA.
In addition to these internal filings, Glenmark Pharma continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.