FDA Updates – New Drug Approvals from November and December 2019

This is a continuation of our new blog series to update you on recent FDA drug approvals, new indications, and other changes! You can find the recap or notable FDA drug changes (AdCom, PDUFDA, etc.) for November and December 2019 below. If we are missing information or you’d like more information about one of the noted changes, feel free to contact us.

Date Name Company Indication
11/4/2019TaliciaRedHill BiopharmaH. pylori infection
11/5/2019ZiextenzoSandozto decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
11/5/2019FluzoneSanofihigh-dose quadrivalent influenza vaccine for adults aged 65 years and older
11/8/2019ReblozylCelgene Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions
11/14/2019BrukinsaBeiGene USAtreatment of adults with mantle cell lymphoma who have received at least one prior therapy
11/14/2019FetrojaShionogicomplicated urinary tract infections (cUTI), including kidney infections, caused by susceptible Gram-negative microorganisms in patients age 18 years or older with few or no alternative treatment options
11/15/2019AdakveoNovartistreatment to reduce the frequency of vaso-occlusive crisis in patients 16 years and older
11/18/2019MiSightCooperVision Incto slow myopia progression in children aged 8 to 12 years
11/18/2019Video ED34-i10T2 duodenoscopePentaxto provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems
11/19/2019AbriladaPfizertreatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis
11/20/2019GivlaariAlnylamTreatment of Adults with Acute Hepatic Porphyria (AHP)
11/21/2019CalquenceAstraZeneca for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
11/21/2019XcopriSK Life ScienceTreatment of Partial-Onset Seizures in Adults
11/21/2019IN.PACT AV drug-coated balloonMedtronic treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis
11/25/2019ExservanAquestive Therapeuticstreatment of patients with amyotrophic lateral sclerosis (ALS)
11/26/2019TULATusker MedicalSystem for In-Office Tympanostomy Tube Placement
11/26/2019OxbrytaGlobal Blood Therapeuticstreatment of sickle cell disease (SCD) in adults and children aged 12 years and older
11/27/2019ToujeoSanofifor blood sugar control in adult and pediatric patients who are ages six years and older. This applies to both type 1 and 2 diabetes
12/3/2019RediTrexCumberland PharmaceuticalsRheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
12/4/2019TecentriqGenentechin combination with chemotherapy nab-paclitaxel (Abraxane, Celgene) and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK mutations
12/5/2019Gilenya GenericsMultiple Companiestreatment of relapsing forms of multiple sclerosis (MS) in adult patients
12/12/2019Xelanz XRPfizer once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers
12/13/2019Vyondys 53Sarepta Therapeuticstreatment of Duchenne Muscular Dystrophy
12/13/2019VascepaAmarin to reduce the risk for cardiovascular (CV) events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors
12/16/2019XtandiPfizer/Astellastreatment of patients with metastatic castration-sensitive prostate cancer (mCSPC)
12/16/2019NouressAvadel Pharmaceuticalsfor Treating Neonate Patients Requiring Total Parental Nutrition (TPN)
12/16/2019EluRyngAmneal PharmaceuticalsContraception
12/19/2019ArazloOrtho Dermatologicsto treat acne vulgaris in individuals aged 9 years and older
12/19/2019PADCEVAstellas treatment of locally advanced or metastatic urothelial cancer that has progressed on chemotherapy and immunotherapy
12/20/2019EnhertuAstraZeneca and Daiichi Sankyo HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
12/20/2019ConjupriCSPC Pharmaceutical GroupTreatment of Hypertension
12/20/2019ErveboMerckprevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older
12/23/2019CaplytaIntra-Cellular Therapies, Inctreatment of schizophrenia in adults
12/23/2019DayvigoEisaitreatment of insomnia in adults
12/23/2019UbrelvyAllerganacute treatment of migraine with or without aura in adults
12/23/2019Apixiban GenericsMicro Labs Limited and Mylanto reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation
12/26/2019Brilliant Blue GDutch Ophthalmic Research Center [DORC]for staining of the internal limiting membrane during vitreoretinal surgery

Stay tuned, as we will continue to update this FDA new drug approval series regularly. Happy 2020!

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