2018 FDA Approvals Summary - PharmaCircle

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 Number

Product Name

Molecule/API Name

Route

125294 761051 761063 761065 761067 761068 761077 761079 761089 761090 761092 761094 761097

761102

761104

761107 761108 761116

GRANIX POTELIGEO EMGALITY TROGARZO

ILUMYA CRYSVITA AIMOVIG PALYNZIQ

AJOVY TAKHZYRO REVCOVI OXERVATE LIBTAYO

ASPARLAS

LUMOXITI

GAMIFANT ULTOMIRIS ELZONRIS

TBO-FILGRASTIM MOGAMULIZUMAB-KPKC GALCANEZUMAB-GNLM

IBALIZUMAB-UIYK TILDRAKIZUMAB-ASMN

BUROSUMAB-TWZA ERENUMAB-AOOE PEGVALIASE-PQPZ FREMANEZUMAB-VFRM LANADELUMAB (SHP643) ELAPEGADEMASE-LVLR CENEGERMIN-BKBJ CEMIPLIMAB-RWLC

CALASPARGASE PEGOL-MKNL MOXETUMOMAB PASUDOTOX-TDFK EMAPALUMAB-LZSG RAVULIZUMAB-CWVZ TAGRAXOFUSP-ERZS

INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION OPHTHALMIC INTRAVENOUS

INTRAVENOUS

INJECTION

INJECTION INJECTION INJECTION

Dosage Form

Company Name

Approval Date

Marketing Status

Application Category

Indication

INJECTABLE RATIOPHARM 2018-07-31

RX

INJECTABLE KYOWA KIRIN 2018-08-08

RX

INJECTABLE ELI LILLY

2018-09-27

RX

INJECTABLE TAIMED

2018-03-06

RX

INJECTABLE SUN GLOBAL

2018-03-20

RX

INJECTABLE ULTRAGENYX 2018-04-17

RX

INJECTABLE AMGEN

2018-05-17

RX

INJECTABLE BIOMARIN

2018-05-24

RX

INJECTABLE TEVA

2018-09-14

RX

INJECTABLE DYAX

2018-08-23

RX

INJECTABLE LEADIANT

2018-10-05

RX

SOLUTION DOMPE

2018-08-22

RX

INJECTABLE REGENERON

2018-09-28

RX

351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a) 351(a)

Neutropenia Mycosis Fungoides Migraine Infections, HIV/AIDS, Other Psoriasis, Other X-Linked Hypophosphatemia Migraine Phenylketonuria Migraine Angioedema, Hereditary, Other SCID, Other Eye Diseases, Corneal Cancer, SCC

INJECTABLE SERVIER

2018-12-20

RX

351(a) Cancer, ALL

INJECTABLE ASTRAZENECA 2018-09-13

RX

INJECTABLE NOVIMMUNE 2018-11-20

RX

INJECTABLE ALEXION

2018-12-21

RX

SOLUTION STEMLINE

2018-12-21

RX

351(a)

351(a) 351(a) 351(a)

Cancer, HCL

Blood Cell Disorders, Other PNH Cancer, BPDCN

All Rights Reserved - PharmaCircle LLC (2019)

FDA Drugs Division - 2018 BLA Approvals (351(k) Biologics)

Application Number

Product Name

Molecule/API Name

125545

761039 761075 761080 761071 761088 761091

RETACRIT

UDENYCA FULPHILA NIVESTYM HYRIMOZ TRUXIMA HERZUMA

EPOETIN ALFA-EPBX

PEGFILGRASTIM-CBQV PEGFILGRASTIM-JMDB

FILGRASTIM-AAFI ADALIMUMAB-ADAZ

RITUXIMAB-ABBS TRASTUZUMAB-PKRB

Route

INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION INJECTION

Dosage Form

Company Name

Approval Date

Marketing Status

Application Category

Indication

INJECTABLE HOSPIRA

INJECTABLE INJECTABLE INJECTABLE INJECTABLE INJECTABLE INJECTABLE

COHERUS MYLAN HOSPIRA SANDOZ CELLTRION CELLTRION

2018-05-15

RX

2018-11-02

RX

2018-06-04

RX

2018-07-20

RX

2018-10-30

RX

2018-11-28

RX

2018-12-14

RX

351(k)

351(k) 351(k) 351(k) 351(k) 351(k) 351(k)

Anemia, Cancer/ChemoInduced Neutropenia Neutropenia Neutropenia Psoriasis, Other Cancer, NHL, Other Cancer, Breast, Other

All Rights Reserved - PharmaCircle LLC (2019)

FDA Vaccines, Blood & Biologics Division - 2018 BLA Approvals (351(a) Biologics)

Application Number

Product Name

125586

ANDEXXA

Molecule/API Name ANDEXANET ALFA

125563

VAXELIS

VAXELIS

Route INJECTION INJECTION

125587

125644 125661

PANZYGA

IMMUNOGLOBULIN G, HUMAN PLASMA-DERIVED

INJECTION

ALBUMINEX SERUM ALBUMIN, HUMAN

JIVI

DAMOCTOCOG ALFA PEGOL

INJECTION INJECTION

Dosage Form

Company Name

Approval Date

Marketing Status

Application Category

Indication

INJECTABLE

PORTOLA

2018-05-03

RX

INJECTABLE

SANOFI PASTEUR

2018-12-26

RX

INJECTABLE OCTAPHARMA 2018-08-02

RX

INJECTABLE

BIO PRODUCTS LABORATORY

2018-06-19

RX

INJECTABLE

BAYER

2018-08-29

RX

351(a) 351(a)

351(a) 351(a) 351(a)

Hemostasis

Infections, Diphtheria, Pertussis, Poliomyelitis, Haemophilus, Hepatitis B, Tetanus

Primary humoral immunodeficiency, Chronic immune thrombocytopenic purpura

Hypovolemia, ascites, hypoalbuminemia

Hemophilia A

All Rights Reserved - PharmaCircle LLC (2019)

FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (1/2)

Application Number

Product Name

Molecule/API Name

Route

Dosage Form

Company Name

Approval Date

Marketing Status

Application Category

Indication

206709

DIACOMIT

STIRIPENTOL

ORAL

CAPSULE

BIOCODEX

2018-08-20

RX

207078

LOKELMA

SODIUM ZIRCONIUM CYCLOSILICATE

ORAL

FOR SUSPENSION ASTRAZENECA 2018-05-18

RX

207924

OLUMIANT

BARICITINIB

ORAL

TABLET

ELI LILLY

2018-05-31

RX

208078

FIRDAPSE

AMIFAMPRIDINE PHOSPHATE

ORAL

TABLET

CATALYST

2018-11-28

RX

208623

GALAFOLD

MIGALASTAT HYDROCHLORIDE

ORAL

CAPSULE

AMICUS

2018-08-10

RX

208627

TPOXX

TECOVIRIMAT

ORAL

CAPSULE

SIGA TECHNO. 2018-07-13

RX

208700

LUTATHERA LUTETIUM DOTATATE LU-177 INTRAVENOUS

SOLUTION AAA USA

2018-01-26

RX

209229

LUCEMYRA

LOFEXIDINE HYDROCHLORIDE

ORAL

TABLET

US WORLDMEDS

2018-05-16

RX

209299

TAVALISSE

FOSTAMATINIB DISODIUM

ORAL

TABLET

RIGEL

2018-04-17

RX

209521

SEYSARA

SARECYCLINE HYDROCHLORIDE

ORAL

TABLET

ALLERGAN

2018-10-01

RX

209627

ANNOVERA

SEGESTERONE ACETATE; ETHINYL ESTRADIOL

VAGINAL

RING

POPULATION COUNCIL

2018-08-10

RX

209816

NUZYRA OMADACYCLINE TOSYLATE

ORAL

TABLET

PARATEK

2018-10-02

RX

209817

NUZYRA OMADACYCLINE TOSYLATE INTRAVENOUS

POWDER PARATEK

2018-10-02

RX

210166

MOTEGRITY

PRUCALOPRIDE

ORAL

TABLET

SHIRE

2018-12-14

RX

210238

DOPTELET AVATROMBOPAG MALEATE

ORAL

TABLET

AKARX

2018-05-21

RX

210303

ZEMDRI

PLAZOMICIN SULFATE INTRAVENOUS

SOLUTION ACHAOGEN

2018-06-25

RX

210365

EPIDIOLEX

CANNABIDIOL

ORAL

SOLUTION GW RESEARCH 2018-09-28

RX

210450

ORILISSA

ELAGOLIX SODIUM

ORAL

TABLET

ABBVIE

2018-07-23

RX

210493

AKYNZEO

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

INTRAVENOUS

POWDER HELSINN

2018-04-19

RX

Type 1 Type 1 Type 1 Type 1

Type 1 Type 1 Type 1 Type 1

Type 1

Type 1

Myoclonic Seizure

Hyperkalemia

Rheumatoid Arthritis, Lambert Eaton Myasthenic Syndrome

Fabry Disease

Infections, Smallpox Cancer, Neuroendocrine

Opioid Dependence

Idiopathic Thrombocytopenic Purpura

Acne

Type 1

Type 1 Type 1 Type 1 Type 1 Type 1 Type 1 Type 1

Contraception

Infections, SSTI Infections, SSTI Constipation, Thrombocytopenia Infections, Urinary Tract Myoclonic Seizure Pain Management,

Type 1 Nausea-Emesis

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