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FDA News Briefs for Monday, December 17, 2018

December 17, 2018

These Food and Drug Administration (FDA) developments came in last Friday:


FDA Approves Second Biosimilar to Herceptin

The FDA approved Herzuma (trastuzumab-pkrb, Celltrion Inc.) as a biosimilar to Herceptin (trastuzumab; Genentech Inc.) for patients with HER2-overexpressing breast cancer. Herzuma is the second Herceptin biosimilar approved by the FDA, the first was Ogivri (trastuzumab-dkst; Mylan). Ogivri was approved in December 2017, but has not yet been launched in the United States. More Information.


FDA Approves New Drug for Chronic Idiopathic Constipation

The FDA approved Motegrity (prucalopride, Shire), an oral serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation in adults. In October 2018, an FDA advisory committee voted unanimously to support approval of prucalopride. More Information.


FDA Expands Indications for Nplate

The FDA expanded indications for Nplate (romiplostim; Amgen Inc.) to include use in pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The agency previously approved Nplate for use in adults. More Information.