The push to receive approval and begin production of Udenyca was due in large part to the quickly increasing cost of Neulasta, which has nearly tripled since its release in 2002.Pelmeg was approved for medical use in the European Union in November 2018.Fulphila was approved for medical use in the European Union in November 2018.Ziextenzo was approved for medical use in the European Union in November 2018.Fulphila was approved for medical use in Canada in December 2018.Grasustek was approved for medical use in the European Union in June 2019.Ziextenzo was approved for medical use in Australia in July 2019.Pelgraz was approved for medical use in Australia in August 2019.Lapelga and Neutropeg were approved for medical use in Australia in August 2019.Pegfilgrastim-bmez (Ziextenzo) was approved for medical use in the United States in November 2019.Cegfila was approved for medical use in the European Union in December 2019.Ziextenzo was approved for medical use in Canada in April 2020.Pegfilgrastim-apgf (Nyvepria) was approved for medical use in the United States in June 2020. Nyvepria was approved for medical use in the European Union in November 2020.Nyvepria was approved for medical use in Canada in October 2020.Stimufend was approved for medical use in the European Union in March 2022.Pegfilgrastim-pbbk (Fylnetra) was approved for medical use in the United States in May 2022.Pegfilgramstim-fpgk (Stimufend) was approved for medical use in the United States in September 2022. References
External links
"Pegfilgrastim". Drug Information Portal. U.S. National Library of Medicine. "FDA notifies Amgen of misbranding of its biological product Neulasta". U.S. Food and Drug Administration (FDA).
This means the defective gene responsible for the disorder is located on an autosome (chromosome 8 is an autosome), and two copies of the defective gene (one inherited from each parent) are required in order to be born with the disorder. The parents of an individual with an autosomal recessive disorder both carry one copy of the defective gene, but usually do not experience any signs or symptoms of the disorder.Two adult siblings, both heterozygous for two particular NBS1 nonsense mutations displayed cellular sensitivity to radiation, chromosome instability and fertility defects, but not the developmental defects that are typically found in other NBS patients. These individuals appear to be primarily defective in homologous recombination, a process that accurately repairs double-strand breaks, both in somatic cells and during meiosis. Diagnosis
Treatment
There is no treatment for NBS; however in those with agammaglobulinemia, intravenous immunoglobulin may be started. Prophylactic antibiotics are considered to prevent urinary tract infections as those with NBS often have congenital kidney malformations. In the treatment of malignancies, radiation therapy, alkylating antineoplastic agents, and epipodophyllotoxins are not used, and methotrexate can be used only with caution; the dose should be limited. Bone marrow transplants and hematopoietic stem cell transplants are also considered in the treatment of NBS. The supplementation of vitamin E is also recommended. A ventriculoperitoneal shunt can be placed in patients with hydrocephalus, and surgical intervention for congenital deformities is also attempted.