Glenmark gets USFDA nod for generic Exjade tablets

Glenmark Pharmaceuticals Inc, USA has received final approval from the United States Food & Drug Administration (FDA) for deferasirox tablets for oral suspension

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Glenmark gets USFDA nod for generic Exjade tablets

Glenmark Pharmaceuticals Inc, USA has received final approval from the United States Food & Drug Administration (FDA) for deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg, the generic version of Exjade tablets for oral suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.

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 US$ 106.4 million.

Also read: Glenmark recalls Ranitidine tablets in US

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

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.

Also read: USFDA red flags Glenmark over batch failure investigations at Baddi facility

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