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Mylan launches two generic medicines

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CANONSBURG — Mylan N.V. on Thursday announced the U.S. launch of a generic version of GlaxoSmithKline’s Rythmol SR, used to help people with symptomatic atrial fibrillation.

Mylan, whose administrative operations are based in Southpointe, said in a press release it received final approval from the U.S. Food and Drug Administration for its Propafenone Hydrochloride extended-release capsules in 225-, 325-, 425-mg doses.

The medicine is indicated to prolong the time to recurrence of symptomatic AF in patients who do not have structural heart disease.

Rythmol had U.S. sales of approximately $100.5 million for the 12 months ending March 31, according to IMS Health.

Mylan also announced the U.S. launch of Azacitidine for injection, in 100-mg/vial. It is a generic version of Celgene’s Vidaza injection, a nucleoside metabolic inhibitor indicated for the treatment of the five French-American-British subtypes of myelodysplastic syndrome, a blood cell disorder that can occur as a result of cancer treatments or can progress to leukemia.

Azacitidine for Injection, had U.S. sales of approximately $236.3 million for the 12 months ending March 31, according to IMS Health.

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