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Glenmark gets USFDA approval for Rythmol SR generic

Press Trust of India  |  New Delhi 

Glenmark Pharmaceuticals has received final approval from the US health regulator for generic version of Rythmol SR capsules, an anti-arrhythmic medication, which treats illnesses associated with rapid heart beats.

"Glenmark Pharmaceuticals Inc., has been granted final approval by the United States Food & Drug Administration (US FDA) for Propafenone Hydrochloride extended-release capsules USP, 225 mg, 325 mg, and 425 mg," Glenmark Pharmaceuticals said in a filing.


Propafenone Hydrochloride extended-release capsules is generic version of GlaxoSmithKline, LLC's Rythmol Capsules.

According to IMS Health sales data for the 12 months to July 2017, Rythmol SR capsules achieved annual sales of approximately USD 69.2 million, Glenmark said.

The company's current portfolio consists of 123 products authorised for distribution in the US marketplace and 63 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.

Glenmark Pharmaceuticals' were trading at Rs 578 on BSE, down 0.47 per cent from previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, September 11 2017. 10:57 IST
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