2018Q1 NDA & BLA New Product Approval …...2018 First Quarter FDA Approvals – NDA & BLA This...
Transcript of 2018Q1 NDA & BLA New Product Approval …...2018 First Quarter FDA Approvals – NDA & BLA This...
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 [email protected].
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