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Lonoctocog alfa

Parecoxib

A letter of non-approval for parecoxib was issued by the FDA in 2005. … It is approved through much of Europe for short term perioperative pain control much in the same way ketorolac (Toradol) is used in the United States.

Meropenem

In August 2017, a combination antibacterial therapy under the market name vabomere was approved for treatment of adult patients with complicated urinary tract infections (cUTI).

Coagulation Factor IX (Recombinant)

Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B). … Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for

Trastuzumab emtansine

Trastuzumab emtansine is marketed under the brand name Kadcyla and is indicated for use in HER2-positive, metastatic breast cancer patients who have already used taxane and/or trastuzumab for metastatic

Bevacizumab

vials formulated for intravenous oncology use. … There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells.

Eptinezumab

[F94,A33105,A33106,A33108] It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.[L12318]

Luspatercept

[A187829,L42455] It was first approved for use in the United States in November 2019 under the brand name Reblozyl® for the treatment of anemia in patients with beta thalassemia who require regular blood … [A187835] Luspatercept's novel mechanism of action, then, is uniquely suited for the treatment of conditions in which late-stage erythropoiesis is defective, such as beta thalassemia and other myelodysplastic

Fosfomycin

[A229338,A230348] It may also be produced synthetically and is commercially available as the disodium salt for intravenous administration and as the calcium or trometamol salt for oral administration. … [A230348] As such there is great interest in exploring the usefulness of fosfomycin for indications beyond the treatment of UTIs.[A230353,A230358]

Infliximab

They are approved for all eligible indications of the reference product. Inflectra, a first biosimilar drug product, was approved in 2016. … It is indicated for the treatment of various inflammatory disorders such as adult or pediatric Chron's disease, adult or pediatric ulcerative colitis, rheumatoid arthritis in combination with methotrexate