2018 FDA Approvals Summary BLA, NDA, & Tentative Approvals Key Drug-Device Supplements PharmaCircle LLC 2019-01-14 FDA Drugs Division - 2018 BLA Approvals (351(a) Biologics) Application Approval Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Indication Number Date Status Category 125294 GRANIX TBO-FILGRASTIM INJECTION INJECTABLE RATIOPHARM 2018-07-31 RX 351(a) Neutropenia 761051 POTELIGEO MOGAMULIZUMAB-KPKC INJECTION INJECTABLE KYOWA KIRIN 2018-08-08 RX 351(a) Mycosis Fungoides 761063 EMGALITY GALCANEZUMAB-GNLM INJECTION INJECTABLE ELI LILLY 2018-09-27 RX 351(a) Migraine 761065 TROGARZO IBALIZUMAB-UIYK INJECTION INJECTABLE TAIMED 2018-03-06 RX 351(a) Infections, HIV/AIDS, Other 761067 ILUMYA TILDRAKIZUMAB-ASMN INJECTION INJECTABLE SUN GLOBAL 2018-03-20 RX 351(a) Psoriasis, Other 761068 CRYSVITA BUROSUMAB-TWZA INJECTION INJECTABLE ULTRAGENYX 2018-04-17 RX 351(a) X-Linked Hypophosphatemia 761077 AIMOVIG ERENUMAB-AOOE INJECTION INJECTABLE AMGEN 2018-05-17 RX 351(a) Migraine 761079 PALYNZIQ PEGVALIASE-PQPZ INJECTION INJECTABLE BIOMARIN 2018-05-24 RX 351(a) Phenylketonuria 761089 AJOVY FREMANEZUMAB-VFRM INJECTION INJECTABLE TEVA 2018-09-14 RX 351(a) Migraine 761090 TAKHZYRO LANADELUMAB (SHP643) INJECTION INJECTABLE DYAX 2018-08-23 RX 351(a) Angioedema, Hereditary, Other 761092 REVCOVI ELAPEGADEMASE-LVLR INJECTION INJECTABLE LEADIANT 2018-10-05 RX 351(a) SCID, Other 761094 OXERVATE CENEGERMIN-BKBJ OPHTHALMIC SOLUTION DOMPE 2018-08-22 RX 351(a) Eye Diseases, Corneal 761097 LIBTAYO CEMIPLIMAB-RWLC INTRAVENOUS INJECTABLE REGENERON 2018-09-28 RX 351(a) Cancer, SCC CALASPARGASE 761102 ASPARLAS INTRAVENOUS INJECTABLE SERVIER 2018-12-20 RX 351(a) Cancer, ALL PEGOL-MKNL MOXETUMOMAB 761104 LUMOXITI INJECTION INJECTABLE ASTRAZENECA 2018-09-13 RX 351(a) Cancer, HCL PASUDOTOX-TDFK 761107 GAMIFANT EMAPALUMAB-LZSG INJECTION INJECTABLE NOVIMMUNE 2018-11-20 RX 351(a) Blood Cell Disorders, Other 761108 ULTOMIRIS RAVULIZUMAB-CWVZ INJECTION INJECTABLE ALEXION 2018-12-21 RX 351(a) PNH 761116 ELZONRIS TAGRAXOFUSP-ERZS INJECTION SOLUTION STEMLINE 2018-12-21 RX 351(a) Cancer, BPDCN All Rights Reserved - PharmaCircle LLC (2019) FDA Drugs Division - 2018 BLA Approvals (351(k) Biologics) Application Approval Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Indication Number Date Status Category Anemia, Cancer/Chemo- 125545 RETACRIT EPOETIN ALFA-EPBX INJECTION INJECTABLE HOSPIRA 2018-05-15 RX 351(k) Induced 761039 UDENYCA PEGFILGRASTIM-CBQV INJECTION INJECTABLE COHERUS 2018-11-02 RX 351(k) Neutropenia 761075 FULPHILA PEGFILGRASTIM-JMDB INJECTION INJECTABLE MYLAN 2018-06-04 RX 351(k) Neutropenia 761080 NIVESTYM FILGRASTIM-AAFI INJECTION INJECTABLE HOSPIRA 2018-07-20 RX 351(k) Neutropenia 761071 HYRIMOZ ADALIMUMAB-ADAZ INJECTION INJECTABLE SANDOZ 2018-10-30 RX 351(k) Psoriasis, Other 761088 TRUXIMA RITUXIMAB-ABBS INJECTION INJECTABLE CELLTRION 2018-11-28 RX 351(k) Cancer, NHL, Other 761091 HERZUMA TRASTUZUMAB-PKRB INJECTION INJECTABLE CELLTRION 2018-12-14 RX 351(k) Cancer, Breast, Other All Rights Reserved - PharmaCircle LLC (2019) FDA Vaccines, Blood & Biologics Division - 2018 BLA Approvals (351(a) Biologics) Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category 125586 ANDEXXA ANDEXANET ALFA INJECTION INJECTABLE PORTOLA 2018-05-03 RX 351(a) Hemostasis Infections, Diphtheria, Pertus- SANOFI 125563 VAXELIS VAXELIS INJECTION INJECTABLE 2018-12-26 RX 351(a) sis, Poliomyelitis, Haemophilus, PASTEUR Hepatitis B, Tetanus Primary humoral immunodefi- IMMUNOGLOBULIN G, HU- 125587 PANZYGA INJECTION INJECTABLE OCTAPHARMA 2018-08-02 RX 351(a) ciency, Chronic immune MAN PLASMA-DERIVED thrombocytopenic purpura BIO PRODUCTS Hypovolemia, ascites, 125644 ALBUMINEX SERUM ALBUMIN, HUMAN INJECTION INJECTABLE 2018-06-19 RX 351(a) LABORATORY hypoalbuminemia 125661 JIVI DAMOCTOCOG ALFA PEGOL INJECTION INJECTABLE BAYER 2018-08-29 RX 351(a) Hemophilia A All Rights Reserved - PharmaCircle LLC (2019) FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (1/2) Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category 206709 DIACOMIT STIRIPENTOL ORAL CAPSULE BIOCODEX 2018-08-20 RX Type 1 Myoclonic Seizure SODIUM ZIRCONIUM 207078 LOKELMA ORAL FOR SUSPENSION ASTRAZENECA 2018-05-18 RX Type 1 Hyperkalemia CYCLOSILICATE 207924 OLUMIANT BARICITINIB ORAL TABLET ELI LILLY 2018-05-31 RX Type 1 Rheumatoid Arthritis, AMIFAMPRIDINE Lambert Eaton Myasthenic 208078 FIRDAPSE ORAL TABLET CATALYST 2018-11-28 RX Type 1 PHOSPHATE Syndrome MIGALASTAT 208623 GALAFOLD ORAL CAPSULE AMICUS 2018-08-10 RX Type 1 Fabry Disease HYDROCHLORIDE 208627 TPOXX TECOVIRIMAT ORAL CAPSULE SIGA TECHNO. 2018-07-13 RX Type 1 Infections, Smallpox 208700 LUTATHERA LUTETIUM DOTATATE LU-177 INTRAVENOUS SOLUTION AAA USA 2018-01-26 RX Type 1 Cancer, Neuroendocrine LOFEXIDINE US 209229 LUCEMYRA ORAL TABLET 2018-05-16 RX Type 1 Opioid Dependence HYDROCHLORIDE WORLDMEDS FOSTAMATINIB Idiopathic Thrombocytopenic 209299 TAVALISSE ORAL TABLET RIGEL 2018-04-17 RX Type 1 DISODIUM Purpura SARECYCLINE 209521 SEYSARA ORAL TABLET ALLERGAN 2018-10-01 RX Type 1 Acne HYDROCHLORIDE SEGESTERONE ACETATE; POPULATION 209627 ANNOVERA VAGINAL RING 2018-08-10 RX Type 1 Contraception ETHINYL ESTRADIOL COUNCIL 209816 NUZYRA OMADACYCLINE TOSYLATE ORAL TABLET PARATEK 2018-10-02 RX Type 1 Infections, SSTI 209817 NUZYRA OMADACYCLINE TOSYLATE INTRAVENOUS POWDER PARATEK 2018-10-02 RX Type 1 Infections, SSTI 210166 MOTEGRITY PRUCALOPRIDE ORAL TABLET SHIRE 2018-12-14 RX Type 1 Constipation, 210238 DOPTELET AVATROMBOPAG MALEATE ORAL TABLET AKARX 2018-05-21 RX Type 1 Thrombocytopenia 210303 ZEMDRI PLAZOMICIN SULFATE INTRAVENOUS SOLUTION ACHAOGEN 2018-06-25 RX Type 1 Infections, Urinary Tract 210365 EPIDIOLEX CANNABIDIOL ORAL SOLUTION GW RESEARCH 2018-09-28 RX Type 1 Myoclonic Seizure 210450 ORILISSA ELAGOLIX SODIUM ORAL TABLET ABBVIE 2018-07-23 RX Type 1 Pain Management, FOSNETUPITANT CHLORIDE HYDROCHLORIDE; 210493 AKYNZEO INTRAVENOUS POWDER HELSINN 2018-04-19 RX Type 1 Nausea-Emesis PALONOSETRON HYDROCHLORIDE All Rights Reserved - PharmaCircle LLC (2019) FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (2/2) Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category 210598 YUPELRI REVEFENACIN INHALATION SOLUTION MYLAN 2018-11-09 RX Type 1 COPD 210656 DAURISMO GLASDEGIB ORAL TABLET PFIZER 2018-11-21 RX Type 1 Cancer, AML 210795 KRINTAFEL TAFENOQUINE SUCCINATE ORAL TABLET GSK 2018-07-20 RX Type 1 Infections, Malaria 210806 PIFELTRO DORAVIRINE ORAL TABLET MSD MERCK 2018-08-30 RX Type 1 Infections, HIV/AIDS 210854 XOFLUZA BALOXAVIR MARBOXIL ORAL TABLET GENENTECH 2018-10-24 RX Type 1 Infections, Influenza LOXO 210861 VITRAKVI LAROTRECTINIB ORAL CAPSULE 2018-11-26 RX Type 1 Cancer, Solid ONCOLOGY 210867 MOXIDECTIN MOXIDECTIN ORAL TABLET MDGH 2018-06-13 RX Type 1 Infections, Onchocerciasis 210868 LORBRENA LORLATINIB ORAL TABLET PFIZER 2018-11-02 RX Type 1 Cancer, NSCLC TABLET, DELAYED COSMO 210910 AEMCOLO RIFAMYCIN ORAL 2018-11-16 RX Type 1 Infections, ETEC RELEASE TECHNOLOGIES 210922 ONPATTRO PATISIRAN SODIUM INTRAVENOUS SOLUTION ALNYLAM 2018-08-10 RX Type 1 Amyloidosis 210923 MULPLETA LUSUTROMBOPAG ORAL TABLET SHIONOGI 2018-07-31 RX Type 1 Thrombocytopenia JANSSEN 210951 ERLEADA APALUTAMIDE ORAL TABLET 2018-02-14 RX Type 1 Cancer, CRPC BIOTECH ERAVACYCLINE Infections, Complicated 211109 XERAVA INTRAVENOUS POWDER TETRAPHASE 2018-08-27 RX Type 1 DIHYDROCHLORIDE Intra-Abdominal 211155 COPIKTRA DUVELISIB ORAL CAPSULE VERASTEM 2018-09-24 RX Type 1 Cancer, CLL Familial Amyloid 211172 TEGSEDI INOTERSEN SODIUM SUBCUTANEOUS SOLUTION AKCEA 2018-10-05 RX Type 1 Polyneuropathy 211192 TIBSOVO IVOSIDENIB ORAL TABLET AGIOS 2018-07-20 RX Type 1 Cancer, AML 211349 XOSPATA GILTERITINIB ORAL TABLET ASTELLAS 2018-11-28 RX Type 1 Cancer, AML 211651 TALZENNA TALAZOPARIB TOSYLATE ORAL CAPSULE PFIZER 2018-10-16 RX Type 1 Cancer, Breast Metastatic LOXO 211710 VITRAKVI LAROTRECTINIB ORAL SOLUTION 2018-11-26 RX Type 1 Cancer, Solid ONCOLOGY SYMDEKO IVACAFTOR; IVACAFTOR, 210491 ORAL TABLET, TABLET VERTEX 2018-02-12 RX Type 1 Cystic Fibrosis (COPACKAGED) TEZACAFTOR All Rights Reserved - PharmaCircle LLC (2019) FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity / New Combination) Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category BICTEGRAVIR SODIUM; GILEAD 210251 BIKTARVY EMTRICITABINE; TENOFOVIR ORAL TABLET 2018-02-07 RX Type 1, 4 Infections, HIV/AIDS, SCIENCES ALAFENAMIDE FUMARATE ARRAY 210496 BRAFTOVI ENCORAFENIB ORAL CAPSULE 2018-06-27 RX Type 1, 4 Cancer, Melanoma Metastatic BIOPHARMA ARRAY 210498 MEKTOVI BINIMETINIB ORAL TABLET 2018-06-27 RX Type 1, 4 Cancer, Melanoma Metastatic BIOPHARMA 211288 VIZIMPRO DACOMITINIB ORAL TABLET PFIZER 2018-09-27 RX Type 1, 4 Cancer, NSCLC Metastatic 210589 OMEGAVEN FISH OIL TRIGLYCERIDES INTRAVENOUS EMULSION FRESENIUS KABI 2018-07-27 RX Type 1, 4 Cholestasis All Rights Reserved - PharmaCircle LLC (2019) FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Active Ingredient) Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category ASCORBIC ACID; POLYETHYLENE