Research & Development
Glenmark Pharmaceuticals granted final FDA approval to market generic version of Rythmol SR
11 September 2017 -

India-based Glenmark Pharmaceuticals (NSE: GLENMARK) has been granted final approval by the US health regulator to market its generic version of Rythmol SR capsules, the company confirmed on Monday.

Rythmol SR capsules are indicated as an anti-arrhythmic medication, used in the treatment of illnesses whose symptoms include rapid heartbeats.

The US Food and Drug Administration (FDA) granted its approval for Propafenone Hydrochloride extended-release capsules USP, 225 mg, 325 mg and 425 mg.

Rythmol SR is a product of GlaxoSmithKline LLC.

The approval marks the company's 123rd product to gain approval for commercialisation in the US marketplace. It also has 63 Abbreviated New Drug Applications (ANDA) currently pending approval with the FDA.