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 |
|---|---|---|---|
| 11/4/2019 | Talicia | RedHill Biopharma | H. pylori infection |
| 11/5/2019 | Ziextenzo | Sandoz | to 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 |
| 11/5/2019 | Fluzone | Sanofi | high-dose quadrivalent influenza vaccine for adults aged 65 years and older |
| 11/8/2019 | Reblozyl | Celgene | Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions |
| 11/14/2019 | Brukinsa | BeiGene USA | treatment of adults with mantle cell lymphoma who have received at least one prior therapy |
| 11/14/2019 | Fetroja | Shionogi | complicated 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 |
| 11/15/2019 | Adakveo | Novartis | treatment to reduce the frequency of vaso-occlusive crisis in patients 16 years and older |
| 11/18/2019 | MiSight | CooperVision Inc | to slow myopia progression in children aged 8 to 12 years |
| 11/18/2019 | Video ED34-i10T2 duodenoscope | Pentax | to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems |
| 11/19/2019 | Abrilada | Pfizer | treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis |
| 11/20/2019 | Givlaari | Alnylam | Treatment of Adults with Acute Hepatic Porphyria (AHP) |
| 11/21/2019 | Calquence | AstraZeneca | for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
| 11/21/2019 | Xcopri | SK Life Science | Treatment of Partial-Onset Seizures in Adults |
| 11/21/2019 | IN.PACT AV drug-coated balloon | Medtronic | treatment of failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis |
| 11/25/2019 | Exservan | Aquestive Therapeutics | treatment of patients with amyotrophic lateral sclerosis (ALS) |
| 11/26/2019 | TULA | Tusker Medical | System for In-Office Tympanostomy Tube Placement |
| 11/26/2019 | Oxbryta | Global Blood Therapeutics | treatment of sickle cell disease (SCD) in adults and children aged 12 years and older |
| 11/27/2019 | Toujeo | Sanofi | for blood sugar control in adult and pediatric patients who are ages six years and older. This applies to both type 1 and 2 diabetes |
| 12/3/2019 | RediTrex | Cumberland Pharmaceuticals | Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis |
| 12/4/2019 | Tecentriq | Genentech | in 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 |
| 12/5/2019 | Gilenya Generics | Multiple Companies | treatment of relapsing forms of multiple sclerosis (MS) in adult patients |
| 12/12/2019 | Xelanz XR | Pfizer | once-daily treatment of adult patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers |
| 12/13/2019 | Vyondys 53 | Sarepta Therapeutics | treatment of Duchenne Muscular Dystrophy |
| 12/13/2019 | Vascepa | Amarin | 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 |
| 12/16/2019 | Xtandi | Pfizer/Astellas | treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) |
| 12/16/2019 | Nouress | Avadel Pharmaceuticals | for Treating Neonate Patients Requiring Total Parental Nutrition (TPN) |
| 12/16/2019 | EluRyng | Amneal Pharmaceuticals | Contraception |
| 12/19/2019 | Arazlo | Ortho Dermatologics | to treat acne vulgaris in individuals aged 9 years and older |
| 12/19/2019 | PADCEV | Astellas | treatment of locally advanced or metastatic urothelial cancer that has progressed on chemotherapy and immunotherapy |
| 12/20/2019 | Enhertu | AstraZeneca and Daiichi Sankyo | HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens |
| 12/20/2019 | Conjupri | CSPC Pharmaceutical Group | Treatment of Hypertension |
| 12/20/2019 | Ervebo | Merck | prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older |
| 12/23/2019 | Caplyta | Intra-Cellular Therapies, Inc | treatment of schizophrenia in adults |
| 12/23/2019 | Dayvigo | Eisai | treatment of insomnia in adults |
| 12/23/2019 | Ubrelvy | Allergan | acute treatment of migraine with or without aura in adults |
| 12/23/2019 | Apixiban Generics | Micro Labs Limited and Mylan | to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation |
| 12/26/2019 | Brilliant Blue G | Dutch 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!
