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

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

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

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

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

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

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; 209381 PLENVU POTASSIUM CHLORIDE; ORAL FOR SOLUTION SALIX 2018-05-04 RX Type 2 Bowel Cleansing SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

211226 KHAPZORY LEVOLEUCOVORIN INTRAVENOUS POWDER SPECTRUM 2018-10-19 RX Type 2 Cancer, Chemo Side Effects

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

207223 DIACOMIT STIRIPENTOL ORAL FOR SUSPENSION BIOCODEX 2018-08-20 RX Type 3 Myoclonic Seizure

206185 XELPROS LATANOPROST OPHTHALMIC EMULSION SUN PHARMA 2018-09-12 RX Type 3 Ocular Hypertension

SUSPENSION, 207356 ARIKAYCE KIT AMIKACIN SULFATE INHALATION INSMED 2018-09-28 RX Type 3 Infections, Respiratory Tract LIPOSOMAL

EFAVIRENZ; LAMIVUDINE; 208255 SYMFI LO TENOFOVIR DISOPROXIL ORAL TABLET MYLAN 2018-02-05 RX Type 3 Infections, HIV/AIDS FUMARATE

GEMCITABINE 208313 INFUGEM INTRAVENOUS SOLUTION SUN PHARM 2018-07-16 RX Type 3 Cancer, Pancreatic Metastatic HYDROCHLORIDE

OCULAR 208742 DEXTENZA DEXAMETHASONE OPHTHALMIC INSERT 2018-11-30 RX Type 3 Ophthalmic Pain THERAPEUTIX

209080 TIGLUTIK KIT RILUZOLE ORAL SUSPENSION ITALFARMACO 2018-09-05 RX Type 3 ALS

209128 DSUVIA SUFENTANIL CITRATE SUBLINGUAL TABLET ACELRX 2018-11-02 RX Type 3 Acute Pain

209184 INBRIJA LEVODOPA INHALATION POWDER ACORDA 2018-12-21 RX Type 3 Parkinson's

CAPSULE, METHYLPHENIDATE 209311 JORNAY PM ORAL EXTENDED IRONSHORE 2018-08-08 RX Type 3 ADHD HYDROCHLORIDE RELEASE

209353 ALTRENO TRETINOIN TOPICAL LOTION DOW 2018-08-23 RX Type 3 Acne

209355 JEMDEL HALOBETASOL PROPIONATE UNKNOWN DOW 2018-11-06 RX Type 3 Psoriasis,

AMANTADINE TABLET, EXTENDED 209410 OSMOLEX ER ORAL OSMOTICA 2018-02-16 RX Type 3 Parkinson's HYDROCHLORIDE RELEASE

XYOSTED 209863 TESTOSTERONE ENANTHATE SUBCUTANEOUS SOLUTION ANTARES 2018-09-28 RX Type 3 Hypoandrogenism AUTOINJECTOR

210115 PROGRAF TACROLIMUS ORAL FOR SUSPENSION ASTELLAS 2018-05-24 RX Type 3 Transplant Rejection

GLYCOPYRRONIUM TOSYL- 210361 QBREXZA TOPICAL CLOTH DERMIRA 2018-06-28 RX Type 3 Hyperhidrosis ATE

CAPSULE, KAPSPARGO 210428 METOPROLOL SUCCINATE ORAL EXTENDED SPIL 2018-01-26 RX Type 3 Hypertension, SPRINKLE RELEASE

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

PHARMACY- 210563 IMBRUVICA IBRUTINIB ORAL TABLET 2018-02-16 RX Type 3 Cancer, MCL CLICS

FOR SUSPENSION, 210655 PERSERIS KIT RISPERIDONE SUBCUTANEOUS EXTENDED INDIVIOR 2018-07-27 RX Type 3 Schizophrenia RELEASE

210793 NUPLAZID PIMAVANSERIN TARTRATE ORAL CAPSULE ACADIA 2018-06-28 RX Type 3 Psychotic Disorders

AQUESTIVE 210833 SYMPAZAN CLOBAZAM ORAL FILM 2018-11-01 RX Type 3 Lennox-Gastaut Syndrome THERAPEUTICS

TABLET, ORALLY 211210 QMIIZ ODT MELOXICAM ORAL TERSERA 2018-10-19 RX Type 3 Osteoarthritis DISINTEGRATING

211358 ORKAMBI IVACAFTOR; LUMACAFTOR ORAL GRANULE VERTEX 2018-08-07 RX Type 3 Cystic Fibrosis

INTRAVENOUS, UNITED Pulmonary Arterial 208276 REMODULIN TREPROSTINIL SOLUTION 2018-07-30 RX Type 3 SUBCUTANEOUS THERAPEUTICS Hypertension

ETHINYL ESTRADIOL; 208612 BALCOLTRA ORAL TABLET AVION 2018-01-09 RX Type 3 Female Contraception LEVONORGESTREL

204441 JYNARQUE TOLVAPTAN ORAL TABLET OTSUKA 2018-04-23 RX Type 3 Polycystic Kidney Disease

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

INSTITUT 206976 LICART DICLOFENAC EPOLAMINE TOPICAL SHAMPOO 2018-12-19 RX Type 3,4 Acute Pain BIOCHIMIQUE

GUAIFENESIN; HYDROCO- 208085 XTRELUS ORAL TABLET ECI 2018-04-25 RX Type 3,4 Cough And Cold DONE BITARTRATE

HALOBETASOL 210566 HALOBETASOL PROPIONATE TOPICAL AEROSOL, FOAM MAYNE 2018-05-24 RX Type 3,4 Psoriasis PROPIONATE FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 4 (New Combination)

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

LAMIVUDINE; TENOFOVIR 22141 CIMDUO ORAL TABLET MYLAN 2018-02-28 RX Type 4 Infections, HIV/AIDS DISOPROXIL FUMARATE

EFAVIRENZ; LAMIVUDINE; 22142 SYMFI TENOFOVIR DISOPROXIL ORAL TABLET MYLAN 2018-03-22 RX Type 4 Infections, HIV/AIDS FUMARATE

EFAVIRENZ, LAMIVUDINE, EFAVIRENZ; LAMIVUDINE; 22343 TENOFOVIR TENOFOVIR DISOPROXIL ORAL TABLET AUROBINDO 2018-08-15 RX Type 4 Infections, HIV/AIDS DISOPROXIL FUMARATE FUMARATE

LAMIVUDINE, LAMIVUDINE; NEVIRAPINE; 205626 NEVIRAPINE, ORAL TABLET MICRO LABS 2018-08-13 RX Type 4 Infections, HIV/AIDS ZIDOVUDINE ZIDOVUDINE

ACETAMINOPHEN; 208653 APADAZ BENZHYDROCODONE ORAL TABLET KEMPHARM 2018-02-23 RX Type 4 Acute Pain HYDROCHLORIDE

AMLODIPINE BESYLATE; 210045 CONSENSI ORAL TABLET KITOV 2018-05-31 RX Type 4 Pain Management CELECOXIB

THERAPEUTICS- 210132 BIJUVA ESTRADIOL; PROGESTERONE ORAL CAPSULE 2018-10-28 RX Type 4 Menopause MD

COBICISTAT; DARUNAVIR ETHANOLATE; 210455 SYMTUZA ORAL TABLET JANSSEN 2018-07-17 RX Type 4 Infections, HIV/AIDS EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

DORAVIRINE; LAMIVUDINE; 210807 DELSTRIGO TENOFOVIR DISOPROXIL ORAL TABLET MSD MERCK 2018-08-30 RX Type 4 Infections, HIV/AIDS FUMARATE

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

MIDAZOLAM 209566 SEIZALAM INTRAMUSCULAR SOLUTION MERIDIAN 2018-09-14 RX Type 5 Status Epilepticus HYDROCHLORIDE

22517 NOCDURNA DESMOPRESSIN ACETATE SUBLINGUAL TABLET FERRING 2018-06-21 RX Type 5 Nocturia

TECHNETIUM TC-99M INTRAVENOUS, RADIOGENIX NORTHSTAR 202158 SODIUM PERTECHNETATE INTRAVESICULAR, SOLUTION 2018-02-08 RX Type 5 Diagnostic Agents SYSTEM MEDICAL GENERATOR OPHTHALMIC

TABLET, EXTENDED 204417 ELEPSIA XR LEVETIRACETAM ORAL SUN PHARMA 2018-12-20 RX Type 5 Epilepsy RELEASE

LUTRATE DEPOT 205054 LEUPROLIDE ACETATE INTRAMUSCULAR FOR SUSPENSION GP-PHARM 2018-08-28 RX Type 5 Cancer, Prostate KIT

BENDAMUSTINE HYDRO- 205580 BELRAPZO IV (INFUSION) SOLUTION EAGLE 2018-05-15 RX Type 5 Cancer, NHL CHLORIDE

207962 ZTLIDO LIDOCAINE TOPICAL PATCH SCILEX 2018-02-28 RX Type 5 Neuropathic Pain

207987 ABLYSINOL ALCOHOL INTRA-ARTERIAL SOLUTION BELCHER 2018-06-21 RX Type 5 Cardiomyopathy

BUPRENORPHINE 208042 CASSIPA HYDROCHLORIDE; SUBLINGUAL FILM TEVA 2018-09-07 RX Type 5 Opioid Dependence NALOXONE HYDROCHLORIDE

CHLORHEXIDINE 3M HEALTH 208288 SOLUPREP GLUCONATE; TOPICAL SOLUTION 2018-08-08 RX Type 5 Infections, Bacterial CARE ISOPROPYL ALCOHOL

THERAPEU- 208564 IMVEXXY ESTRADIOL VAGINAL INSERT 2018-05-29 RX Type 5 Vaginal Atrophy TICSMD

DOXERCALCI- 208614 DOXERCALCIFEROL INJECTION INJECTABLE HOSPIRA 2018-07-24 RX Type 5 Secondary Hyperparathyroidism FEROL

208647 EZALLOR ROSUVASTATIN ORAL CAPSULE SUN PHARMAL 2018-12-18 RX Type 5 Hypertriglyceridemia

208901 TOLSURA ITRACONAZOLE ORAL CAPSULE MAYNE 2018-12-11 RX Type 5 Skin Infections, Fungal

VANCOMYCIN 208910 FIRVANQ KIT ORAL FOR SOLUTION RXMTM 2018-01-26 RX Type 5 Diarrhea HYDROCHLORIDE

208912 DEXYCU KIT DEXAMETHASONE INTRAOCULAR SUSPENSION EYEPOINT 2018-02-09 RX Type 5 Eye Inflammation,

INTRAVENOUS, 209191 BORTEZOMIB BORTEZOMIB POWDER HOSPIRA 2018-07-12 RX Type 5 Cancer, Multiple Myeloma SUBCUTANEOUS All Rights Reserved - PharmaCircle LLC (2019) FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 5 (New Formulation or Manufacturer) (2/3)

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

IV (INFUSION), INTRAMUSCULAR, ATROPINE 209260 ATROPINE SULFATE SUBCUTANEOUS, SOLUTION FRESENIUS KABI 2018-01-26 RX Type 5 Intoxication/Poisoning SULFATE INTRAOSSEOUS, ENDOTRACHEAL

VANCOMYCIN VANCOMYCIN 209481 HYDROCHLO- INTRAVENOUS POWDER MYLAN 2018-07-10 RX Type 5 Sepsis HYDROCHLORIDE RIDE

209607 AZEDRA IOBENGUANE I 131 INJECTION INJECTABLE PROGENICS 2018-07-30 RX Type 5 Pheochromocytoma

SUSPENSION, ARISTADA INI- 209830 ARIPIPRAZOLE LAUROXIL INTRAMUSCULAR EXTENDED ALKERMES 2018-06-29 RX Type 5 Schizophrenia TIO KIT RELEASE

209844 LYMEPAK DOXYCYCLINE HYCLATE ORAL TABLET CHARTWELL 2018-06-15 RX Type 5 Infections, Lyme Disease

210308 YONSA ABIRATERONE ACETATE ORAL TABLET SUN PHARMA 2018-05-22 RX Type 5 Cancer, CRPC Metastatic

210331 YUTIQ FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT EYEPOINT 2018-10-12 RX Type 5 Uveitis

SUSPENSION/ 210565 INVELTYS LOTEPREDNOL ETABONATE OPHTHALMIC KALA 2018-08-22 RX Type 5 Eye Inflammation DROPS

210607 ARAKODA TAFENOQUINE SUCCINATE ORAL TABLET 60 DEGREES 2018-08-08 RX Type 5 Infections, Malaria

210913 CEQUA CYCLOSPORINE OPHTHALMIC SOLUTION SUN PHARMA 2018-08-14 RX Type 5 Dry Eye Syndrome

INTRAMUSCULAR, 210997 GLYRX-PF GLYCOPYRROLATE SOLUTION EXELA PHARMA 2018-07-11 RX Type 5 Anesthesia INTRAVENOUS

211158 TIGECYCLINE TIGECYCLINE INTRAVENOUS POWDER AMNEAL 2018-08-02 RX Type 5 Infections, SSTI

LAMIVUDINE; TENOFOVIR 211284 TEMIXYS ORAL TABLET CELLTRION 2018-11-16 RX Type 5 Infections, HIV/AIDS DISOPROXIL FUMARATE

SPY AGENT INTRAVENOUS, 211580 INDOCYANINE GREEN POWDER NOVADAQ 2018-11-21 RX Type 5 Diagnostic Agents GREEN KIT INTERSTITIAL

ATROPINE 212319 ATROPINE INTRAMUSCULAR SOLUTION RAFA LABS 2018-07-09 RX Type 5 Intoxication/Poisoning AUTOINJECTOR

LAMIVUDINE TENOFOVIR LAMIVUDINE; TENOFOVIR 22344 ORAL TABLET AUROBINDO 2018-05-15 RX Type 5 Infections, HIV/AIDS DISOPROXIL DISOPROXIL FUMARATE FUMARATE

Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing Application Indication

208744 TIGECYCLINE TIGECYCLINE INTRAVENOUS POWDER ACCORD 2018-01-18 RX Type 5 Infections, SSTI

ARGATROBAN 209552 IN SODIUM ARGATROBAN INTRAVENOUS SOLUTION AUROBINDO 2018-11-27 RX Type 5 Anticoagulant, antithrombotic CHLORIDE

CALCIUM GLUCONATE IN 210906 CALCIUM GLUCONATE INTRAVENOUS SOLUTION HQ SPECIALITY 2018-10-29 RX Type 5 Hypocalcemia SODIUM CHLORIDE

READYPREP CHLORHEXIDINE 207964 TOPICAL CLOTH MEDLINE 2018-11-20 RX Type 5 Infections, Surgical Preparation CHG GLUCONATE

PRIMATENE 205920 EPINEPHRINE INHALATION AEROSOL ARMSTRONG 2018-11-07 OTC Type 5,8 Asthma MIST

FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 9 (New Indication …)

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

208855 VERZENIO ABEMACICLIB ORAL TABLET ELI LILLY 2018-02-26 RX Type 9 Cancer, Breast Metastatic

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category

MONOMETHYL 210296 MONOMETHYL FUMARATE ORAL CAPSULE BANNER 2018-11-16 TENTAPP Type 2 MS, Relapsing Remitting FUMARATE

210661 PEMETREXED PEMETREXED INJECTION INJECTABLE APOTEX 2018-03-28 TENTAPP Type 2 Cancer, NSCLC Metastatic

INJECTION, 210136 BRIXADI BUPRENORPHINE SUBCUTANEOUS EXTENDED BRAEBURN 2018-12-21 TENTAPP Type 3, 4 Opioid Dependence RELEASE

LAMIVUDINE; TENOFOVIR LAMIVUDINE; TENOFOVIR 205493 ORAL TABLET MICRO LABS 2018-01-25 TENTAPP Type 4 Infections, HIV/AIDS, Other DISOPROXIL DISOPROXIL FUMARATE FUMARATE

DOLUTEGRAVIR DOLUTEGRAVIR; 210237 EMTRICITABINE; EMTRICITABINE; ORAL TABLET MYLAN 2018-02-09 TENTAPP Type 4 Infections, HIV/AIDS, Other TENOFOVIR TENOFOVIR ALAFENAMIDE

MERCK SHARP 209764 LUSDUNA INSULIN GLARGINE INJECTION INJECTABLE 2018-02-22 TENTAPP Type 5 Diabetes, Type 2 DOHME

LOPINAVIR; 210540 LOPINAVIR; RITONAVIR ORAL UNKNOWN MYLAN 2018-08-16 TENTAPP Type 5 Infections, HIV/AIDS, Other RITONAVIR

205389 EFAVIRENZ EFAVIRENZ ORAL TABLET MICRO LABS 2018-02-23 TENTAPP Type 5 Infections, HIV/AIDS, Other

CABAZITAXEL 207970 CABAZITAXEL INJECTION INJECTABLE ACTAVIS 2018-01-17 TENTAPP Type 5 Cancer, CRPC Metastatic INJECTION

210326 FULVESTRANT FULVESTRANT INJECTION INJECTABLE FRESENIUS KABI 2018-06-29 TENTAPP Type 5 Cancer, Breast, Other

210850 SINCALIDE SINCALIDE INJECTION INJECTABLE MAIA 2018-02-23 TENTAPP Type 5 Diagnostic Agents, Other

BENDA- BENDAMUSTINE 210601 MUSTINE HY- IV (INFUSION) SOLUTION APOTEX 2018-11-13 TENTAPP Type 5 Cancer, CLL HYDROCHLORIDE DROCHLORIDE

Application Marketing Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Indication Number Status Category 17 ALPHA- AUTOINJECTORS, 21945 MAKENA HYDROXYPROGESTERONE INJECTION AMAG 2018-02-14 RX Supplement Preterm Birth DISPOSABLE CAPROATE

TOUJEO MAX INSULIN GLARGINE INJECTION PENS, 206538 INJECTION SANOFI 2018-03-26 RX Supplement Diabetes SOLOSTAR RECOMBINANT DISPOSABLE

AUTOINJECTORS, 125472 ACTEMRA TOCILIZUMAB INJECTION CHUGAI 2018-11-19 RX Supplement Rheumatoid Arthritis DISPOSABLE

SPECIALTY 207534 SYMJEPI EPINEPHRINE INJECTION ADAMIS 2018-09-27 RX Supplement Anaphylaxis SYRINGES

Allergic Rhinitis PREFILLED Urticaria 103976 XOLAIR OMALIZUMAB INJECTION GENENTECH 2018-09-28 RX Supplement SYRINGE Asthma Sinusitis

NOVOLIN N INJECTION PENS, 19959 INSULIN ISOPHANE INJECTION NOVO NORDISK 2018-06-01 OTC Supplement Diabetes (FlexPen) DISPOSABLE

NOVOLIN 70/30 INSULIN, INJECTION PENS, 19991 INJECTION NOVO NORDISK 2018-06-01 OTC Supplement Diabetes (FlexPen) HUMAN RECOMBINANT DISPOSABLE

NOVOLIN R INSULIN, INJECTION PENS, 19938 INJECTION NOVO NORDISK 2018-06-01 OTC Supplement Diabetes (FlexPen) HUMAN RECOMBINANT DISPOSABLE