Apotex introduces IVRA™ (Melphalan) hydrochloride injection: First ready to dilute liquid formulation of Melphalan injection approved via 505(b)( 2 ) NDA in the United States
May 9, 2025Weston, Florida (May 09, 2025) – Apotex Corp. today launched IVRA™ (Melphalan) hydrochloride injection 90mg/ml multidose vial ("IVRA"), first ready-to-dilute liquid formulation of Melphalan injection approved via 505(b)( 2 ) NDA in the United States.
IVRA is an alkylating drug indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate, and will be distributed primarily through hospital and institutional channels.
"The launch of IVRA highlights Apotex's uncompromising dedication to access, innovation, and patient care," said Christine Baeder, President, Apotex USA. "As we introduce our novel ready-to-dilute liquid formulation of Melphalan injection approved via 505(b)( 2 ) NDA in the United States, we reinforce our commitment to bringing much-needed products that support patients on their health journeys."
Please refer to the complete prescribing information, patient information leaflet, warnings and precautions, adverse reactions, and contraindications.
About Apotex
Apotex Corp., headquartered in Weston, Florida, is an affiliate of Apotex Inc. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic and innovative pharmaceutical and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.
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