Published Online: Friday, June 10, 2016
Mylan is launching generic equivalents to Celgene’s Vidaza injection, 100 mg/vial, and GlaxoSmithKline’s Rythmol SR.
The FDA granted approval to Mylan’s abbreviated new drug applications for the 2 products: azacitidine for injection and propafenone hydrochloride extended-release capsules USP, 225 mg, 325 mg, and 425 mg.
The former product may be used to treat the 5 French-American-British (FAB) subtypes of myelodysplastic syndrome, which is a blood cell disorder that can occur after cancer treatments.
The latter product can be used to prolong the time to recurrence of symptomatic atrial fibrillation in patients with episodic atrial fibrillation who do not have structural heart disease.
Azacitidine had US sales of $236 million for the fiscal year ending on March 31, 2016, according to IMS Health, while propafenone hydrochloride had US sales of $100 million during the same year.
The most common adverse effects associated with Vidaza are nausea, anemia, vomiting, and pyrexia.
Dizziness, heart palpitations, chest pain, and dyspnea are the most common adverse effects linked to the use of Rythmol SR.