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Glenmark gets USFDA approval for Rythmol SR generic

Glenmark gets USFDA approval for Rythmol SR generic

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

“Glenmark Pharmaceuticals Inc., USA 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 BSE filing.

Propafenone Hydrochloride extended-release capsules are 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 authorized for distribution in the US marketplace and 63 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.

Source: PTI
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