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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.

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

Lonoctocog alfa

Cefepime

[A2457,A249050] Cefepime is normally used to treat severe nosocomial pneumonia and infections caused by multi-resistant microorganisms such as _Pseudomonas aeruginosa_, and is also indicated for the empirical

Enoxaparin

Enoxaparin is a common low-molecular-weight heparin (LMWH) used in the prevention and management of various thromboembolic disorders. Initially approved by the FDA in 1993, it is administered by a subcutaneous or intravenous injection an...

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

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

Vedolizumab

[L48216] Vedolizumab was developed by Takeda and approved by the FDA under the brand name ENTYVIO for the maintenance therapy of moderately to severely active Ulcerative Colitis and Crohn’s Disease … however, the selective activity of vedolizumab against α4β7 integrin has been thought to contribute to its more favorable safety profile compared to its predecessor natalizumab, the first integrin receptor

Eptinezumab

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

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).