FDA approves Actelion sNDA for second generation Veletri for injection
The US Food and Drug Administration (FDA) approved Actelion Pharmaceuticals' supplemental new drug application (sNDA) for second generation Veletri (epoprostenol) for injection.
Veletri (epoprostenol) for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.
Actelion Pharmaceuticals president Shal Jacobovitz said, "Second generation VELETRI provides patients and their caregivers a treatment option that allows patients to have more flexibility in their daily lives."
The company expects to make Veletri available in 2 vial strengths, 0.5mg and 1.5mg. The new 0.5mg vial is recommended for patients using final concentrations of veletri less than 15,000ngml.
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