The Ephemeris

Anti-amyloid antibody

Aduhelm aducanumab-avwa
Leqembi lecanemab-irmb
Kisunla donanemab-azbt
Leqembi Iqlik lecanemab-irmb, subcutaneous

Regulatory records

Advisory committee record
Federal Register notices

Cholinesterase inhibitor

Cognex tacrine hydrochloride
Aricept donepezil hydrochloride
Exelon rivastigmine tartrate
Razadyne galantamine hydrobromide
Aricept ODT donepezil hydrochloride
Razadyne ER galantamine hydrobromide
Adlarity donepezil hydrochloride
Zunveyl benzgalantamine gluconate

NMDA receptor antagonist

Namenda memantine hydrochloride
Namenda XR memantine hydrochloride

Amyloid PET imaging agent

Amyvid florbetapir f-18
Vizamyl flutemetamol f-18
Neuraceq florbetaben f-18

Combination

Namzaric donepezil hydrochloride; memantine hydrochloride

Atypical antipsychotic

Rexulti brexpiprazole

Tau PET imaging agent

Tauvid flortaucipir f-18

Not yet classified

3M Health Care (Infection Prevention Division) SoluPrep™
AbbVie Inc. AGN-151586
Abeona Therapeutics, Inc. prademagene zamikeracel manufactured at your Cleveland
Acacia Pharma Ltd Barhemsys
Accord BioPharma Inc. INTP1
Accord Healthcare Inc. bendamustine hydrochloride
AcelRx Pharmaceuticals, Inc. DSUVIA
Acer Therapeutics Inc. sodium phenylbutyrate
Achieve Life Sciences, Inc. cytisinicline
Actavis, L.L.C. Pemetrexed Injection)
Actavis LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals U.S.A. Inc. Pemetrexed
Adamis Pharmaceuticals Corporation Naloxone HCI
Adello Biologics, LLC Theragrastim.! We have completed our review of this application
AFT Pharmaceuticals Ltd. sirolimus
Agile Therapeutics, Inc. levonorgestrel/ethinyl estradiol
Akebia Therapeutics, Inc. vadadustat
Akeso Biopharma Co., Ltd. AK105
Alkermes, Inc. Lybalvi
Almatica Pharma, LLC zolpidem tartrate
Althera Life Sciences, LLC rosuvastatin
Alvotech USA Inc. AVTO5
Amgen Inc. Kanjinti
Amneal EU, Limited phenylephrine hydrochloride
Amphastar Pharmaceuticals, Inc. We also acknowledge receipt of your amendment dated as SP which was not reviewed
Amryt Pharmaceuticals DAC Filsuvez
Antares Pharma, Inc. hydrocortisone sodium phosphate
AOP Orphan Pharmaceuticals GmbH landiolol
Apiject Systems Corp. glycopyrrolate
Applied Therapeutics, Inc. govorestat
Aquestive Therapeutics Inc. dibutepinephrine
Ardelyx, Inc. tenapanor hydrochloride
Armstrong Pharmaceuticals Primatene Mist
ARS Pharmaceuticals, Inc. Neffy
Ascelia Pharma AB
Ascendis Pharma Bone Diseases A/S palopegteriparatide
Astellas Pharma US, Inc. IZERVAY
AstraZeneca AB Breztri Aerosphere
AstraZeneca Pharmaceuticals LP anifrolumab
Atara Biotherapeutics, Inc. tabelecleucel®) @)
AuroMedics Pharma LLC Cyclophosphamide
AVEO Pharmaceuticals, Inc. tivozanib hydrochloride
Azurity Pharmaceuticals, Inc. sitagliptin
B. Braun Medical, Inc. Acetaminophen
Bausch Health Ireland Limited fluorescein sodium
Baxter Healthcare Corporation DAPZURA RT
Bayer HealthCare LLC Naproxen sodium
Belcher Pharmaceuticals, LLC. Ablysinol
BendaRx USA Corporation bendamustine
Bio-Thera Solutions Ltd. BAT1706
Biogen, Inc.
Biohaven Therapeutics, Ltd. troriluzole
Bioprojet Pharma Wakix
Bioverativ USA, Inc. sutimlimab
Botanix SB Inc. sofpironium bromide
Braeburn Inc. BRIXADI
Braeburn Pharmaceuticals Inc. BRIXADI
Braintree Laboratories, Inc. Suflave
Bridge Regulatory Affairs, LLC octreotide hydrochloride extended- release
Bristol-Myers Squibb dapagliflozin
Cadence Pharmaceuticals Ofirmev
Camargo Pharmaceutical Services Mycapssa
Capricor, Inc. deramiocel
Celitrion, Inc. CT-P17
CellTrans Inc. Donislecel manufactured at your Chicago
CELLTRION, Inc. Steqeyma
Checkpoint Therapeutics, Incorporated cosibelimab
Chelsea Therapeutics, Inc. NORTHERA
Chemo Research, S.L. dienogest
Chiesi USA, Inc. PRX-102
Cingulate Therapeutics, LLC dexmethylphenidate hydrochloride
Cipla USA, Inc.
Citius Pharmaceuticals, Inc. Lymphir
Clarus Therapeutics, Inc. testosterone undecanoate
CLASS 2 RESUBMISSION Romidepsin
Clearside Biomedical, Inc. XIPERE
CMP Development LLC sildenafil
Coherus BioSciences, Inc. toripalimab-tpzi
Conjupro Biotherapeutics Inc. irinotecan liposome
CooperSurgical, Inc. Paragard
Corium, Inc. ADLARITY
CorMedix Inc. taurolidine
CSL Behring LLC CSL312
Cyclomedica Australia Pty Ltd. Technegas™ Technetium Tc-99m carbon aerosol
Daiichi Sankyo, Inc. this action below
DBV Technologies S.A. Peanut Allergen Extract manufactured at your location
Defender Pharmaceuticals, Inc scopolamine
Delcath Systems, Incorporated Melblez
Disc Medicine, Inc. bitopertin
Dow Pharmaceutical Sciences, Inc. halobetasol propionate
Dr. Reddy’s Laboratories, Inc. AVT03
DURECT Corporation POSIMIR
Eagle Pharmaceuticals, Inc. Fulvestrant
ELC Group Lutrate®
Elevar Therapeutics, Inc. rivoceranib
Eli Lilly and Company lebrikizumab
EMD Serono, Inc. cladribine
Emory Partners, LLC Dyanavel XR
Esteve Pharmaceuticals, S.A. celecoxib
Evergreen Theragnostics, Inc.
Evofem, Inc. Amphora
Evoke Pharma, Inc. Gimoti
Evolus, Inc. otulinum toxin Type A
Eyenovia, Inc. MYDCOMBI
Fabre-Kramer Pharmaceuticals, Inc. Gepirone Hydrochloride Extended Release
The Feinstein Institute for Medical Research Fluorodopa F
Fennec Pharmaceuticals, Inc. PEDMARK
Fera Pharmaceuticals, LLC Avaclyr
Ferring Pharmaceuticals Inc. progesterone
Fidelity BioPharma Co. Ontralfy
Fresenius Kabi USA, LLC MSB11456
Galderma R&D, LLC this action
Galephar Pharmaceutical Research Inc. Legubeti
Gan & Lee Pharmaceuticals
Genentech, Incorporated XOFLUZA
GeNO LLC GENOsyl™ ©®
Genzyme Corporation tolebrutinib
Gilead Sciences, Inc. lenacapavir
GlaxoSmithKline LLC Exdensur lepemokimab-ulaa)
Glenmark Pharmaceuticals, Inc. GSP
Grace Therapeutics U.S., Inc. nimodipine
Green Cross Corporation immune globulin
Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc. the following drug product: > Atazanavir Sulfate
Heron Therapeutics, Inc. Zynrelef
Hikma Pharmaceuticals USA Inc. phenobarbital sodium
Hospira, Inc. Daptomycin
HQ Specialty Pharma Corporation Meropenem
Hugel, Inc letibotulinumtoxinA
Immedica Pharma AB
Immunomedics, Inc sacituzumab govitecan
Impax Laboratories, LLC Crexont Extended Release
Ingenus Pharmaceuticals, LLC Cyclophosphamide
Innocoll Pharmaceuticals bupivacaine hydrochloride collagen-matrix implants
InnoPharma Licensing LLC Acetaminophen
Institut Biochimique SA (IBSA) diclofenac epolamine
IntelGenx Corp. RizaFilm
International Medication Systems, Limited Epinephrine
Ipsen Biopharm Ltd. relabotulinumtoxin A
Ironshore Pharmaceuticals & Development, Inc. Jornay PM Modified Release
ITM Solucin GmbH MPA
Janssen Biotech, Inc. amivantamab hyaluronidase
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Kala Pharmaceuticals, Inc. Eysuvis
Kashiv BioSciences, LLC TPI-120
King Pharmaceuticals, Inc. sumatriptan
Kyowa Pharmaceutical, Inc. istradefylline
Laboratorios Farmacéuticos ROVI, S.A. Risvan
Lannett Holdings, Inc. Cocaine Hydrochloride
Laurus Generics, Inc.
LEO Pharma A/S tralokinumab
Lexicon Pharmaceuticals, Inc. sotagliflozin
LIB Therapeutics, Inc. Lerochol
Liqmeds Worldwide Limited mycophenolate mofetil
lpsen Biopharmaceuticals Inc. palovarotene
lterum Therapeutics U.S. Ltd. sulopenem etzadroxil
Lupin Limited (Biotech Division) LUBT004
Lykos Therapeutics this action
Mallinckrodt Hospital Products IP Limited Terlivaz
Mallinckrodt Pharmaceuticals Ireland Ltd terlipressin
Mapi Pharma Ltd. glatiramer acetate epi
Marius Pharmaceuticals, LLC testosterone undecanoate
medac Gesellschaft fur klinische Spezialpraparate mbH Grafapex
MedicaSafe, Inc.
MediWound, Ltd. “concentrate of proteolytic enzymes enriched
MEDRx USA, Inc.
Meitheal Pharmaceuticals Inc. fosfomycin
Merck & Co., Inc. Suvorexant
Mesoblast, Inc. remestemcel-L manufactured at your Singapore location
Metacel Pharmaceuticals, LLC Ozobax
Milestone Pharmaceuticals USA, Inc. etripamil
Minerva Neurosciences, Inc roluperidone
Mylan GmbH insulin glargine
Mylan Laboratories Limited Acetaminophen ©
Mylan Pharmaceuticals Inc. the following drug product: > Abacavir
Mylan Pharmaceuticals Inc., a Viatris Company the following drug product: > Abacavir
Nanocopoeia, LLC this action
NeuroDerm, Ltd. carbidopa levodopa
Nevakar, Inc. Norepinephrine Bitartrate
nnoPharma Licensing LLC Acetaminophen njection
Nobelpharma Co., Ltd. sirolimus
NorthStar Medical Radioisotopes, LLC TechneGen Generator
Novartis Pharmaceuticals Corporation inclisiran
Novitium Pharma LLC Hydroxychloroquine Sulfate
Novo Nordisk NNC0148-0287
Ocular Therapeutix, Inc. DEXTENZA
Ocuvex Therapeutics, Inc. brimonidine tartrate
Omeros Corporation OMS721
Orexo AB Naloxone hydrochloride
Organon, Inc. Gepirone hydrochloride
Orphan Therapeutics, LLC Lucassin
Orphazyme A/S arimoclomol
Otsuka Pharmaceutical Company, Ltd. ABILIFY MAINTENA
OWP Pharmaceuticals, Inc. this action
Par Sterile Products, LLC Micafungin
Pfizer Inc. Trazimera
Pfizer Ireland Pharmaceuticals MOD-4023
AB Pharmaceuticals, LLC the following drug product: > Efavirenz
PharmaEssentia Corporation P1101
Pharmaxis Ltd. Bronchitol
Phathom Pharmaceuticals, Inc. Voquezna
Pierre Fabre Pharmaceuticals Inc. tabelecleucel®
Polarean Inc. Xenoview
Provention Bio, Inc. PRV-031
Proximagen, LLC Nayzilam
PTC Therapeutics, Inc. vatiquinone
RB Health (US) LLC naproxen sodium |)
Recordati Rare Diseases Inc. Cystadrops
Recro Pharma Inc. Meloxicam
RedHill Biopharma Ltd. Rizaport
Regeneron Pharmaceuticals, Inc. BLA
REGENXBIO, Inc. clemidsogene lanparvovee
Replimune, Inc. vusolimogene oderparepvec
ResQ Pharma
Revance Therapeutics, Inc. daxibotulinumtoxinA
Ricon Pharma, LLC Cyclophosphamide
Rocket Pharmaceuticals, Inc. marnetegragene autotemcel manufactured
Rosemont Pharmaceuticals Holdings, Inc. valacyclovir
Roxane Laboratories, Inc. Cyclophosphamide
Salamandra, LLC rosuvastatin
Samsung Bioepis Co., Ltd. Pyzchiva
Sandoz Inc. EG12014
sanofi-aventis U.S. LLC Fexinidazole
Santen, Inc. Omlonti
Saol International Development Limited sodium dichloroacetate
Sarepta Therapeutics, Inc. Vyondys
Sarfez Pharmaceuticals Inc. pd Pe or to section
Scholar Rock, Inc.
Scienture Inc. losartan potassium
Scilex Pharmaceuticals, Inc. ZTlido
scPharmaceuticals, Inc. Furoscix™ Furosemide)
scPharmaceuticals Services, Inc Furoscix™ “
Sedor Pharmaceuticals, LLC Sesquient
Seikagaku Corporation
Sentynl Therapeutics, Inc. copper histidinate
SFJ Pharmaceuticals, Inc. We have completed our review of this application
Shandong Luye Pharmaceutical Co., Ltd. Rykindo
Shanghai Auzone Biological Technology Co., Ltd. this action below
Shilpa Medicare Limited bortezomib
Spectrum Pharmaceuticals, Inc. SPI-2012
Spes Pharmaceuticals Inc. fosaprepitant
SQ Innovation, Inc. furosemide
Stealth BioTherapeutics Inc. elamipretide
StemCyte, Inc. Hematopoietic Progenitor Cells
Sun Pharma Advanced Research Company Limited Elepsia XR
Sun Pharma Global FZE Levetiracetam
Sun Pharmaceutical Industries Limited nilotinib
Sunovion Pharmaceuticals Inc. Kynmobi
Supernus Pharmaceuticals, Inc. viloxazine hydrochloride
Swedish Orphan Biovitrum AB (publ) sirolimus
SYDNEXIS Inc. atropine sulfate
Takeda Pharmaceuticals U.S.A., Inc. Eohilia
Tanvex BioPharma USA, Inc. TX05
Telix Pharmaceuticals (US) Inc. this action
Teva Neuroscience, Inc. risperidone
Teva Pharmaceuticals, Inc. TVB-009
Teva Pharmaceuticals USA Fulvestrant
Teva Women’s Health, Inc. progesterone
Therakind Limited Jylamvo
TherapeuticsMD, Inc. estradiol
Thomas Chaly, Ph.D., FAIC Fluorodopa F
Trevena, Inc. Oliceridine
Tris Pharma, Inc. oxybate
UGB, Inc. UCB4940
Ultragenyx Pharmaceutical Inc. rebisufligene etisparvovec
Unicycive Therapeutics Inc. oxylanthanum carbonate
United Therapeutics Corporation treprostinil
University of California San Francisco Floretyrosine F
Valeant Pharmaceuticals Ireland tetracaine hydrochloride
Venatorx Pharmaceuticals, Inc.
Vero Biotech, LLC GENOsyl® © Delivery
Verrica Pharmaceuticals Inc. cantharidin
ViiV Healthcare Company CABENUVA®
Vyluma, Inc. atropine sulphate
Xbrane Biopharma AB We have completed our review of this application
Xellia Pharmaceuticals, ApS Vancomycin
Xeris Pharmaceuticals, Inc. Gvoke
Xspray Pharma AB nilotinib
XTM Consulting LLC
Zealand Pharma US, Inc. glepaglutide
Zhejiang Novus Pharmaceuticals Co. Ltd. Vancomycin Hydrochloride
Zydus Worldwide DMCC sitagliptin

Ophthalmology

Aldeyra Therapeutics reproxalap
Outlook Therapeutics ONS-5010 (bevacizumab-vikg)

Endocrinology

Corcept Therapeutics relacorilant

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