2018Q1NDA&BLANewProductApprovalSummaryReport

v2018-03-13PharmaCircleLLC

2018 First Quarter FDA Approvals – NDA & BLA

This report provides a tabular summary of the first quarter 2018 U.S. FDA New Drug and Biological therapeutic product approvals from the Drug and the Vaccines, Blood and Biologics Divisions. The summary includes all NDA and BLA approvals while excluding ANDA approvals. This list does not include reagent product approvals of the Vaccines, Blood and Biologics Division. The list does not include PMA and 510(k) product approvals and clearances. Unless otherwise noted all approvals are New Drug Approvals as defined by the FDA. The product list was prepared using the PharmaCircle FDA Product and Pipeline & Products Intelligence modules and cross referenced with the FDA website. In addition to the usual first quarter NDA and BLA approvals the list includes two products, Makena SC Auto-injector and Toujeo SoloSTAR presentations that were approved as supplements to existing NDA approvals rather than as separate NDAs. The Supplement status of these products is noted in the table. Questions concerning this report and the information contained within should be forwarded to

PharmaCircle at info@pharmacircle.com.

2018Q1 NDA & BLA Approvals

Product Name Company Route Branch DD Category Application

Number Approval Date FDA Classification Dosage Form Molecule Type Molecules

January

Balcoltra Neuvosyn Laboratories Oral Oral Tablet 208612 2018-01-09 Type 3 Oral Tablet small molecule ethinylestradiol

levonorgestrel

Jevtana Allergan Infusion IV Injection Solution 207970 2018-01-17 Tentative Approval Injection Solution small molecule cabazitaxel

Tigecycline Accord Healthcare Infusion IV Injection Lyophilized

Powder for Solution 208744 2018-01-18 Type 5 Injection

Lyophilized Powder for

Solution

small molecule tigecycline

Lamivudine, Tenofovir Disoproxil Fumarate

Micro Labs Oral Oral Tablet 205493 2018-01-25 Type 4

(Tentative Approval)

Oral Tablet small molecule lamivudine

tenofovir disoproxil fumarate

Lutathera Advanced

Accelerator Applications

Infusion IV Injection Solution 208700 2018-01-26 Type 1 Injection Solution peptide lutetium 177Lu oxodotreotide

Firvanq CutisPharma Oral Oral Powder for Solution 208910 2018-01-26 Type 5 Oral Powder for

Solution peptide vancomycin hydrochloride

Atropine Sulfate Fresenius Kabi USA

Infusion IM, Infusion SC, Intraosseous, Infusion IV, Intratracheal

Injection Solution 209260 2018-01-26 Other Injection Solution small molecule anhydrous atropine sulfate

Metoprolol Succinate

Sun Pharmaceutical

Industries Oral

Oral Modified Release, Oral

Capsule 210428 2018-01-26 Type 3 Oral Capsule small molecule metoprolol succinate

February

Symfi Lo Mylan Oral Oral Tablet 208255 2018-02-05 Type 3 Oral Tablet small molecule lamivudine efavirenz

tenofovir disoproxil fumarate

Biktarvy Gilead Sciences Oral Oral Tablet 210251 2018-02-07 Type 1/4 Oral Tablet small molecule

emtricitabine tenofovir alafenamide

fumarate bictegravir sodium

Radiogenix System

NorthStar Medical

Radioisotopes Injectable IV Injection Solution 202158 2018-02-08 Type 5 Injection Solution small molecule sodium pertechnetate

Tc 99m

Dexycu Kit Icon Bioscience Intraocular

Ocular Implants, Rods,

Microcapsules, Injection

Suspension

208912 2018-02-09 Type 5 Injection Suspension small molecule dexamethasone

Dolutegravir, Emtricitabine,

Tenofovir Alafenamide

Mylan Laboratories Oral Oral Tablet 210237 2018-02-09

Type 4 (Tentative Approval)

Oral Tablet small molecule emtricitabine dolutegravir

tenofovir alafenamide

Symdeko Vertex Pharmaceuticals Oral Oral Tablet 210491 2018-02-12 Type 1 Oral Tablet small molecule ivacaftor

tezacaftor

Makena SC Auto-injector

AMAG Pharmaceuticals Injectable SC

Concentrated Suspension/Viscous

Solution Autoinjectors,

Disposable, Other Oil Formulations

21945 2018-02-14 NDA Supplement Injection Solution small molecule

17 alpha-hydroxyprogesterone

caproate

Erleada Aragon Pharmaceuticals Oral Oral Tablet 210951 2018-02-14 Type 1 Oral Tablet small molecule apalutamide

Osmolex ER Osmotica Pharmaceutical Oral

Oral Modified Release, Oral

Tablet 209410 2018-02-16 Type 3 Oral Tablet small molecule amantadine

hydrochloride

2018Q1 NDA & BLA Approvals

Product Name Company Route Branch DD Category Application

Number Approval Date FDA Classification Dosage Form Molecule Type Molecules

IMBRUVICA Pharmacyclics Oral Oral Tablet 210563 2018-02-16 Type 3 Oral Tablet small molecule ibrutinib

Lusduna Merck and Co. Injectable SC Injection Solution 209764 2018-02-22 Type 5

(Tentative Approval)

Injection Solution protein insulin glargine

Efavirenz Micro Labs Oral Oral Tablet 205389 2018-02-23 Type 5

(Tentative Approval)

Oral Tablet small molecule efavirenz

Apadaz KemPharm Oral Prodrugs Small

Molecule Abuse Resistant,

Oral Tablet 208653 2018-02-23 Type 4 Oral Tablet small molecule acetaminophen

benzhydrocodone

Sincalide Maia Pharmaceuticals Injectable IV Injection Lyophilized

Powder For Solution 210850 2018-02-23 Type 5

Injection Lyophilized Powder for

Solution peptide sincalide

Verzenio Eli Lilly Oral Oral Tablet 208855 2018-02-26 Type 9 Oral Tablet small molecule abemaciclib

Ztlido SCILEX Pharmaceuticals Transdermal Transdermal Patch 207962 2018-02-28 Type 5 Transdermal

Patch small molecule lidocaine

Cimduo Mylan Laboratories Oral Oral Tablet 22141 2018-02-28 Type 4 Oral Tablet small molecule

lamivudine tenofovir disoproxil

fumarate

March

Trogarzo Biogen Infusion IV,

Injectable IM, Injectable SC

Injection Solution 761065 2018-03-06 BLA Injection Solution antibody ibalizumab

Ilumya Merck Injectable SC Prefilled Syringes 761067 2018-03-20 BLA Injection Solution antibody tildrakizumab

Toujeo SoloSTAR Sanofi Injectable SC Injection Pens,

Disposable 206538 2018-03-26 NDA Supplement Injection Solution protein insulin glargine

Pemetrexed Apotex Infusion IV Injection Lyophilized Powder For Solution 210661 2018-03-28

Type 2 (Tentative Approval)

Injection Lyophilized Powder for

Solution

small molecule pemetrexed disodium heptahydrate

Symfi Mylan Laboratories Oral Oral Tablet 22142 2018-03-29 Type 4 Oral Tablet small molecule

lamivudine efavirenz

tenofovir disoproxil fumarate

Bendamustine Hydrochloride

Eagle Pharmaceuticals Infusion IV Injection Liquid 205580 2018-03-30

Type 5 (Tentative Approval)

Injection Liquid small molecule bendamustine hydrochloride

Classification Meaning Type 1 New molecular entity Type 2 New active ingredient Type 3 New dosage form Type 4 New combination Type 5 New formulation or other differences Type 6 New indication or claim, same applicant [no longer used] Type 7 Previously marketed but without an approved NDA Type 8 Rx to OTC Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval Type 1/4 Type 1, New molecular entity, and Type 4, New combination Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form Type 2/4 Type 2, New active ingredient and Type 4, New combination Type 3/4 Type 3, New Dosage Form, and Type 4, New combination