Pharmaceutical – Page 3 – Global Reach Health

August 28, 2019

Nourianz Approved to Treat Off Episodes of Parkinson’s Disease

August 28, 2019 – The U.S. FDA has approved NourianzTM (istradefylline), manufactured by Kiowa Kirin, for use as an adjunctive treatment for adults who are also taking levodopa/carbidopa, have Parkinson's disease, and are experiencing off episodes.

August 28, 2019

FDA Issues Safety Communication Regarding Use of Hepatitis C Drugs

August 28, 2019 – The U.S. FDA has received reports of rare worsening liver function or liver failure in patients with moderate to severe liver impairment who have received the following treatments for chronic hepatitis C virus (HCV)

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.

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).