Glenmark gets USFDA’s final nod for Deferasirox tablets

PTI New Delhi | Updated on January 07, 2020 Published on January 07, 2020

Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US health regulator for Deferasirox tablets for oral suspension.

“Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & 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 BSE.

The tablet is 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 approximately USD 106.4 million (about Rs 750 crore).

Glenmark’s current portfolio consists of 165 products authorised for distribution in the US market and 43 ANDAs 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.

Shares of Glenmark Pharmaceuticals were trading 1.37 per cent higher at Rs 344.30 apiece in the morning trade on BSE.

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Published on January 07, 2020
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