Rx Product News (April 2019)
Manufactured By: Xellia Pharmaceuticals
Indication: FDA officials have approved premixed vancomycin injections in ready-to-use (RTU) bags to treat bone infections, ineffective endocartitis, lower respiratory tract infections, septicaemia, and skin and skin structure infections. Vancomycin is a glycopeptide antibacterial, making it useful for treating many different bacterial infections. The single-dose flexible RTU bags in which the Vancomycin will be distributed can last up to 16 months when stored at room temperature.
Dosage Form: RTU Injection
For More Information: xellia.com
Manufactured By: Novartis
Indication: Novartis has been granted FDA approval for Egaten (triclabendazole), a therapy for fascioliasis. Fascioliasis is a rare tropical disease caused by certain species of parasitic flatworm if ingested in contaminated food or water. Treatment for this rare disease has previously been neglected in the United States, making Egaten the first FDA-approved treatment for fascioliasis. In the acute phase, the disease can cause abdominal pain, diarrhea, eosinophilia, fever, and nausea and can become a chronic and obstructive health condition if untreated.
Dosage Form: Tablets
For More Information: Novartis.com
Manufactured By: Janssen Pharmaceuticals
Indication: Officials with the FDA have approved a split-dosing regimen for Darzalex (daratumumab) to treat multiple myeloma. This revised label allows patients to receive an infusion split over the course of 2 days, as opposed to receiving it all at once. Darzalex was initially approved for single-dose infusions in 2015.
Dosage Form: intravenous infusion
For More Information: Darzalex.com
Manufactured By: Amgen
Indication: Recently, a Delaware jury delivered a verdict that will uphold the validity of Amgen’s patent for Repatha (evolocumab). Repatha is indicated to prevent heart attack, stroke, and coronary revascularization in adults with cardiovascular disease; to reduce low-density lipoprotein (LDL) cholesterol levels in patients with hypercholesterolemia; and to reduce LDL cholesterol levels in patients with a familial history of hypercholesterolemia. Repatha works by binding to the PCSK9 gene to inhibit LDL cholesterol (LDL-C) levels from binding to the gene, reducing the level of LDL-C in the blood.
Dosage Form: Subcutaneous injection
For More Information: repatha.com