Mylan NV, a global pharmaceutical company, announced the US launch of Propafenone hydrochloride extended-release capsules USP, 225 mg, 325 mg, 425 mg, a generic version of GlaxoSmithKline's Rythmol SR.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
Propafenone hydrochloride extended-release capsules USP, 225 mg, 325 mg, 425 mg, had U.S. sales of approximately $100.5 million for the 12 months ending March 31, 2016, according to IMS Health.
Currently, Mylan has 254 ANDAs pending FDA approval representing $108.3 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.