August 29, 2019 – The U.S. FDA has granted tentative approval to Mylan’s generic for Eli Lilly’s Alimta® (pemetrexed injection). The product is indicated to treat of pleural mesothelioma and non-small cell lung cancer.
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 – 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 – 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).
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 – 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 – 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 – 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.