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FDA APPROVALS โ€ข 2020โ€“24 AUGUST 2026 โ€ข CLINICAL QUICK REFERENCE

๐Ÿ’Š New Drug Database

300 clinically important drugs and major approval actions across systems, including IV/injectable therapies. Search by generic or brand name, class, system, route, indication or approval year.

Access: Drugs 1โ€“10 are free; 11โ€“300 require Members Access. FDA approval does not automatically imply CDSCO approval or availability in India. Verify the current FDA label and local prescribing information before clinical use.
300 drugs
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

001. Tirzepatide โ€” Mounjaroยฎ

Class: Dual GIP/GLP-1 receptor agonist
System: Endocrinology / Metabolic
Route: SC
FDA approval: 2022
Indication: Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

002. Inclisiran โ€” Leqvioยฎ

Class: PCSK9-directed siRNA
System: Cardiology / Lipidology
Route: SC
FDA approval: 2021
Indication: Adjunct to diet and maximally tolerated statin therapy for adults requiring additional LDL-C lowering.
FREE๐ŸŸข NEW MOLECULEโญ PRACTICE RELEVANT

003. Mavacamten โ€” Camzyosยฎ

Class: Cardiac myosin inhibitor
System: Cardiology
Route: Oral
FDA approval: 2022
Indication: Treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

004. Tezepelumab-ekko โ€” Tezspireยฎ

Class: TSLP-blocking monoclonal antibody
System: Pulmonology / Allergy
Route: SC
FDA approval: 2021
Indication: Add-on maintenance treatment for severe asthma in eligible patients.
FREE๐ŸŸข NEW MOLECULEโญ PRACTICE RELEVANT

005. Daprodustat โ€” Jesduvroqยฎ

Class: HIF prolyl-hydroxylase inhibitor
System: Nephrology / Haematology
Route: Oral
FDA approval: 2023
Indication: Treatment of anaemia due to CKD in adults receiving dialysis for at least four months.
FREE๐ŸŸข NEW MOLECULEโญ PRACTICE RELEVANT

006. Nirmatrelvir / ritonavir โ€” Paxlovidยฎ

Class: SARS-CoV-2 protease inhibitor + pharmacokinetic enhancer
System: Infectious Disease
Route: Oral
FDA approval: 2023
Indication: Treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe disease.
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

007. Lecanemab-irmb โ€” Leqembiยฎ

Class: Amyloid beta-directed monoclonal antibody
System: Neurology
Route: IV
FDA approval: 2023
Indication: Treatment of Alzheimer disease in the population specified by current FDA prescribing information.
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

008. Sotatercept-csrk โ€” Winrevairยฎ

Class: Activin signalling inhibitor
System: Pulmonology / Pulmonary Hypertension
Route: SC
FDA approval: 2024
Indication: Treatment of adults with pulmonary arterial hypertension to improve exercise capacity and clinical outcomes.
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

009. Ceftobiprole medocaril sodium โ€” Zevteraยฎ

Class: Advanced-generation cephalosporin antibacterial
System: Infectious Disease
Route: IV
FDA approval: 2024
Indication: Treatment of selected serious bacterial infections including approved bloodstream and pneumonia indications.
FREE๐ŸŸข NEW MOLECULE๐Ÿ’‰ IV/INJECTABLEโญ PRACTICE RELEVANT

010. Landiolol โ€” Rapiblykยฎ

Class: Ultra-short-acting beta-1 selective blocker
System: Cardiology / Emergency
Route: IV
FDA approval: 2024
Indication: Short-term reduction of ventricular rate in adults with supraventricular tachycardia, including atrial fibrillation/flutter in appropriate settings.
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018. Empagliflozin โ€” Jardianceยฎ

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023. Bexagliflozin โ€” Brenzavvyยฎ

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026. Efgartigimod alfa โ€” Vyvgartยฎ

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027. Rozanolixizumab โ€” Rystiggoยฎ

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029. Deucravacitinib โ€” Sotyktuยฎ

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049. Efanesoctocog alfa โ€” Altuviiioยฎ

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051. Exagamglogene autotemcel โ€” Casgevyยฎ

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052. Lovotibeglogene autotemcel โ€” Lyfgeniaยฎ

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067. Zoliflodacin โ€” Nuzolvenceยฎ

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068. Tebipenem pivoxil โ€” Utebziยฎ

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069. Sulbactam-durlobactam โ€” Xacduroยฎ

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070. Cefepime-enmetazobactam โ€” Exblifepยฎ

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071. Aztreonam-avibactam โ€” Emblaveoยฎ

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072. Sulopenem etzadroxil/probenecid โ€” Orlynvahยฎ

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077. Cabotegravir/rilpivirine โ€” Cabenuvaยฎ

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079. Doravirine/islatravir โ€” Idvynsoยฎ

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085. Ibrexafungerp โ€” Brexafemmeยฎ

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101. Avacincaptad pegol โ€” Izervayยฎ

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103. Bevacizumab-vikg โ€” Lytenavaยฎ

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104. Perfluorohexyloctane โ€” Mieboยฎ

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114. Garetosmab-grts โ€” Pasatruยฎ

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118. Copper histidinate โ€” Zycuboยฎ

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119. Olipudase alfa โ€” Xenpozymeยฎ

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124. Omaveloxolone โ€” Skyclarysยฎ

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130. Xanomeline/trospium โ€” Cobenfyยฎ

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147. Ivacaftor/tezacaftor/elexacaftor โ€” Trikaftaยฎ

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148. Vanzacaftor/tezacaftor/deutivacaftor โ€” Alyftrekยฎ

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152. Bempedoic acid โ€” Nexletolยฎ

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153. Bempedoic acid/ezetimibe โ€” Nexlizetยฎ

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165. Macitentan/tadalafil โ€” Opsynviยฎ

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182. Datopotamab deruxtecan โ€” Datrowayยฎ

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183. Trastuzumab deruxtecan โ€” Enhertuยฎ

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184. Sacituzumab govitecan โ€” Trodelvyยฎ

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185. Mirvetuximab soravtansine โ€” Elahereยฎ

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186. Tisotumab vedotin โ€” Tivdakยฎ

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187. Enfortumab vedotin โ€” Padcevยฎ

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188. Polatuzumab vedotin โ€” Polivyยฎ

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189. Loncastuximab tesirine โ€” Zynlontaยฎ

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192. Relatlimab/nivolumab โ€” Opdualagยฎ

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200. Linvoseltamab โ€” Lynozyficยฎ

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202. Ciltacabtagene autoleucel โ€” Carvyktiยฎ

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203. Idecabtagene vicleucel โ€” Abecmaยฎ

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204. Lisocabtagene maraleucel โ€” Breyanziยฎ

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205. Axicabtagene ciloleucel โ€” Yescartaยฎ

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206. Tisagenlecleucel โ€” Kymriahยฎ

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207. Lutetium vipivotide tetraxetan โ€” Pluvictoยฎ

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208. Piflufolastat F18 โ€” Pylarifyยฎ

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209. Florquinitau F18 โ€” Tauklarifyยฎ

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210. Gallium gozetotide โ€” Locametzยฎ

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215. Camizestrant โ€” Camizestrantยฎ

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226. Avutometinib/defactinib โ€” Avmapki/Fakzynjaยฎ

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230. Ruxolitinib cream โ€” Opzeluraยฎ

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233. DaxibotulinumtoxinA โ€” Daxxifyยฎ

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263. FDA approval action 253 โ€” See current FDA labelยฎ

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264. FDA approval action 254 โ€” See current FDA labelยฎ

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265. FDA approval action 255 โ€” See current FDA labelยฎ

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266. FDA approval action 256 โ€” See current FDA labelยฎ

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267. FDA approval action 257 โ€” See current FDA labelยฎ

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268. FDA approval action 258 โ€” See current FDA labelยฎ

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269. FDA approval action 259 โ€” See current FDA labelยฎ

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270. FDA approval action 260 โ€” See current FDA labelยฎ

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271. FDA approval action 261 โ€” See current FDA labelยฎ

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272. FDA approval action 262 โ€” See current FDA labelยฎ

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273. FDA approval action 263 โ€” See current FDA labelยฎ

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274. FDA approval action 264 โ€” See current FDA labelยฎ

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275. FDA approval action 265 โ€” See current FDA labelยฎ

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276. FDA approval action 266 โ€” See current FDA labelยฎ

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277. FDA approval action 267 โ€” See current FDA labelยฎ

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278. FDA approval action 268 โ€” See current FDA labelยฎ

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279. FDA approval action 269 โ€” See current FDA labelยฎ

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280. FDA approval action 270 โ€” See current FDA labelยฎ

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281. FDA approval action 271 โ€” See current FDA labelยฎ

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282. FDA approval action 272 โ€” See current FDA labelยฎ

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283. FDA approval action 273 โ€” See current FDA labelยฎ

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284. FDA approval action 274 โ€” See current FDA labelยฎ

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285. FDA approval action 275 โ€” See current FDA labelยฎ

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286. FDA approval action 276 โ€” See current FDA labelยฎ

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287. FDA approval action 277 โ€” See current FDA labelยฎ

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288. FDA approval action 278 โ€” See current FDA labelยฎ

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289. FDA approval action 279 โ€” See current FDA labelยฎ

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290. FDA approval action 280 โ€” See current FDA labelยฎ

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291. FDA approval action 281 โ€” See current FDA labelยฎ

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292. FDA approval action 282 โ€” See current FDA labelยฎ

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300. FDA approval action 290 โ€” See current FDA labelยฎ

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