The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
| Organization: | FDA |
|---|---|
| Category: | Governmental Organizations |
| URL: | https://www.fda.gov/ |
August 8, 2018, The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.
Lusutrombopag is an orally bioavailable thrombopoietin receptor (TPOR) agonist developed by Shionogi & Company (Osaka, Japan). TPOR is a regulatory target site for endogenous thrombopoietin, which acts as a primary cytokine to promote megakaryocyte proliferation and differentiation, and affect other hematopoietic lineages as well, including erythroid, granulocytic and lymphoid lineages [A36736]. Thrombocytopenia, which indicates abnormally low levels of platelets, is a common complication related to chronic liver disease.
Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). The phosphate content is 0.015 mmol/mL.
On July 23, 2018, Abbott's key product, elagolix, was approved by the US Food and Drug Administration, which will be used to treat the pain caused by endometriosis and become the indication for more than 10 years. Come to the first new oral medication.
On July 20, GlaxoSmithKline (GSK) and Medicines for Malaria Venture announced that the US FDA has approved the marketing of its Krintafel (tafenoquine) for the treatment of P. vivaxmalaria.
This is the first new drug to prevent Plasmodium vivax malaria, and the 23rd new drug approved by the US FDA this year.
The approved Krintafel (tafenoquine) is a derivative of 8-aminoquinoline that is therapeutically active at all stages of the life cycle of Plasmodium vivax.
The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.
July 13, 2018, The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.
On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Zemdri (plazomicin) is used in adult patients with complex urinary tract infections (cUTI, including pyelonephritis) caused by certain Enterobacteriaceae bacterial infections with very limited or no treatment options. This drug is an intravenous infusion drug. , once a day.
