FDA Confirms Para IV Patent Litigation for Ferric Carboxymaltose (Injectafer) Inj
ST. GALLEN, SWITZERLAND, March 19, 2024 /PRNewswire/ -- CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III* 1 to improve exercise capacity.2 Ferinject has now received marketing authorization in 87 countries worldwide.
SHIRLEY, N.Y.--(BUSINESS WIRE)--American Regent, Inc., a Daiichi Sankyo Group company, today announced results from the phase 3 HEART-FID trial of INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF). While there was a numerical improvement in the hierarchical composite endpoint, the trial did not meet statistical significance on the primary endpoint, which was a hierarchical composite of death and heart failure hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.1 The HEART-FID trial was designed as a single pivotal study instead of two based upon a special protocol assessment with the U.S. Food and Drug Administration (FDA). As a result, the study included a significance level for the final analysis of 0.0099 for the primary endpoint preserving the overall significance at 0.01.1 The safety profile of ferric carboxymaltose injection was consistent with previous reports with no new safety concerns identified.1
Daiichi Sankyo is expanding the label of its iron replacement injectable, Injectafer, into a first-of-its-kind indication, according to the company — iron deficiency in adult patients with heart failure in a bid to expand exercise capacity.
Emcure Pharmaceuticals Limited (EPL) has announced the launch of Orofer FCM 750, a new extension of its parenteral iron brand containing Ferric carboxymaltose (FCM).
CSL Vifor and Fresenius Kabi announced on Nov. 28. 2022 that China’s National Medical Products Administration (NMPA) has approved Ferinject (ferric carboxymaltose), a preparation for intravenous iron therapy for the treatment of iron deficiency in adult patients for whom oral iron preparations are ineffective or cannot be used. Ferinject has now received marketing authorization in 85 countries worldwide.
CSL Vifor and Fresenius Kabi today announced that China’s National Medical Products Administration (NMPA) has approved Ferinject®, a preparation for intravenous iron therapy for the treatment of iron deficiency in adult patients for whom oral iron preparations are ineffective, oral iron preparations cannot be used or for whom there is a clinical need to deliver iron rapidly. Ferinject® has now received marketing authorization in 85 countries worldwide.
FDA Confirms Paragraph IV Patent Litigation for Ferric Carboxymaltose Inj
FDA Confirms Para IV Patent Litigation for Ferric Carboxymaltose Injection
Vifor Pharma Group and its partner American Regent, Inc., a Daiichi Sankyo Group company, today announced that they have reached settlement agreements with Mylan Laboratories Ltd., and Sandoz, Inc., that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the U.S. Food and Drug Administration to market a generic version of Injectafer