GlobalReach Health – Page 97 – Global Reach Health

August 26, 2019

Taltz Receives New Indication for Ankylosing Spondylitis

August 26, 2019 – The U.S. FDA has approved a new indication for Taltz® (ixekizumab), manufactured by Eli Lilly. The product is now indicated to treat adult patients who have active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).

August 21, 2019

Brand Medications with Generic Alternatives Anticipated to be Approved in October

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA's MedWatch Adverse Event Reporting Program online, by mail, or by fax.

August 20, 2019

Myobloc Receives New Indication

August 20, 2019 – The U.S. FDA has approved a new indication for Myobloc® (rimabotulinumtoxinB), manufactured by US WorldMeds, to treat chronic sialorrhea (excessive drooling) in adults.

July 26, 2019

FDA Issues Safety Communication for Xeljanz

July 26, 2019 – The U.S. FDA has issued a safety communication cautioning that Xeljanz® (tofacitinib) and Xeljanz XR® (tofacitinib), manufactured by Pfizer, may increase the risk of blood clots and death when taken at higher doses.

July 25, 2019

Accrufer Approved to Treat Iron Deficiency

July 25, 2019 – The U.S. FDA has approved AccruferTM (ferric maltol), manufactured by Shield Therapeutics, to treat iron deficiency in adults. The product is a new means of treating iron deficiency compared

December 21, 2018

Elzonris Receives Approval to Treat Rare Blood Cancer

December 21, 2018 – The U.S. FDA has approved ElzonrisTM (tagraxofusp-erzs), manufactured by Stemline Therapeutics, to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in patients two years of age and older. Elzonris is the first FDA-approved therapy for BPDCN.

December 21, 2018

Ultomiris Approved to Treat Rare Blood Disorder

December 21, 2018 – The U.S. FDA has approved UltomirisTM (ravulizumab), manufactured by Alexion Pharmaceuticals, to treat adult patients who have paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder.

December 20, 2018

Asparlas Approved to Treat Acute Lymphoblastic Leukemia

December 20, 2018 – The U.S. FDA has approved AsparlasTM (calaspargase pegol-mknl), manufactured by Servier Pharmaceuticals, for use in combination with chemotherapy to treat patients who are between the ages of one month and 21 years, and have acute lymphoblastic leukemia (ALL).