FDA New Molecular Entities [2011-November 2024] 第2頁

  Drug Name Active Ingredient Combo/single ATC Index AHFS Class Date of Approval Mechanism Treatment TFDA approval
173 Oxbryta voxelotor Single B06AX03 20:92 2019/12/18 HbS polymerization inhibitor To treat sickle cell disease  
174 Pyrukynd mitapivat Single B06AX04 20:92 2022/2/17 pyruvate kinase activator To treat hemolytic anemia in pyruvate kinase deficiency 　
175 Enjaymo sutimlimab-jome Single L04AJ04 20:92 2022/2/4 complement C1 protein inhibitor To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease 　
176 Corlanor ivabradine Single C01EB17 24:04 2015/5/27 inhibits cardiac pacemaker current To reduce hospitalization from worsening heart failure. 　
177 Camzyos mavacamten Single C01EB24 24:04 2022/4/28 cardiac myosin inhibitor To treat certain classes of obstructive hypertrophic cardiomyopathy 　
178 Attruby acoramidis Single C01EB25* 24:04 2024/11/22 TTR stabilizer To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis 　
179 Vyndaqel tafamidis meglumine Single N07XX08 24:04 2019/6/10 binds transthyretin to slow amyloid formation To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults 　
180 Kynamro mipomersen sodium Single C10AX11 24:06 2013/2/22 　 To treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). 　
181 Repatha evolocumab Single C10AX13 24:06 2015/9/4 PCSK9 inhibitor To treat certain patients with high cholesterol 　
183 Praluent alirocumab Single C10AX14 24:06 2015/7/24 PCSK9 inhibitor To treat certain patients with high cholesterol 　
184 Nexletol bempedoic acid Single C10AX15 24:06 2020/2/26 ACL inhibitor To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C 　
185 Leqvio inclisiran Single C10AX16 24:06 2021/12/22 silence PCSK9 to reduce PCSK9 protein in hepatocyte cells To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy 　
186 Evkeeza evinacumab-dgnb Single C10AX17 24:06 2021/2/25 ANGPTL3 inhibitor To treat homozygous familial hypercholesterolemia 　
187 Verquvo vericiguat Single C01DX22 24:12 2021/1/22 stimulates sGC To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure 　
188 Opsumit macitentan Single C02KX04 24:12 2013/11/1 　 To treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation. 　
189 Adempas riociguat Single C02KX05 24:12 2013/10/25 　 To treat adults with two forms of pulmonary hypertension. 　
190 Rapiblyk landiolol Single C07AB14 24:20 2024/11/22 beta-1-adrenoreceptor antagonist To treat supraventricular tachycardia 　
191 Kerendia finerenone Single C03DA05 24:32 2021/7/9 blocks MR mediated sodium reabsorption and MR overactivation To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes 　
192 Entresto sacubitril, valsartan Combo C09DX04 24:32 2015/7/24 angiotensin receptor neprilysin inhibitor To treat heart failure 　
193 Inpefa sotagliflozin Single A10BK06 24:40 2023/5/26 SGLT2 and SGLT1 inhibitor To treat heart failure 　
194 Tryvio aprocitentan Single C02KN01 24:52 2024/3/19 endothelin antagonist To treat hypertension 　
195 Olinvyk oliceridine Single N02AX07 28:08 2020/8/14 opioid agonist To manage acute pain in certain adults 　
196 Aptiom eslicarbazepine acetate Single N03AF04 28:12 2013/11/14 voltage-gated sodium channel inhibitor As an add-on medication to treat seizures associated with epilepsy. 　
197 Diacomit stiripentol Single N03AX17 28:12 2018/8/23 increases GABA by inhibiting GABA transaminase and reducing GABA uptake To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam 　
198 Briviact brivaracetam Single N03AX23 28:12 2016/3/22 binds SV2A and modulating synaptic GABA release To treat partial onset seizures in patients age 16 years and older with epilepsy. 　
199 Epidiolex cannabidiol Single N03AX24 28:12 2018/6/27 GPR55 and TRP cation channel inhibitor; enhances activity of serotonin 1A receptor, glycine receptors a1 and a3, and TRPA1. To treat rare, severe forms of epilepsy 　
200 Xcopri cenobamate Single N03AX25 28:12 2019/12/12 voltage-gated Na channel inhibitor To treat partial onset seizures 　
201 Ztalmy ganaxolone Single N03AX27 28:12 2022/3/18 GABAA receptor modulator To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder 　
202 Onfi clobazam Single 　 28:12 2011/11/18 GABAA receptor agonist For use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. 　
203 Caplyta lumateperone tosylate Single N05AD10 28:16 2019/12/20 5-HT antagonist and D2 postsynaptic antagonist To treat schizophrenia 　
204 Lybalvi olanzapine, samidorphan Combo N05AH53 28:16 2021/5/28 dopamine and serotonin type 2 antagonist To treat schizophrenia and certain aspects of bipolar I disorder 　
205 Aristada aripiprazole lauroxil Single N05AX12 28:16 2015/10/21 a prodrug of aripiprazole, acting as a D2 and 5-HT1A partial agonist To treat adults with schizophrenia 　
206 Vraylar cariprazine Single N05AX15 28:16 2015/9/25 D2, D3, 5-HT1A receptor partial agonist To treat schizophrenia and bipolar disorder in adults 　
207 Rexulti brexpiprazole Single N05AX16 28:16 2015/7/24 norepinephrine α1B, α2C, α1D, and α1A antagonist To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder 　
208 Nuplazid pimavanserin Single N05AX17 28:16 2016/5/27 5-HT2A inverse agonist and antagonis To treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease 　
209 Exxua gepirone Single N06AX19 28:16 2023/9/22 5HT1A agonist To treat major depressive disorder 　
210 Brintellix vortioxetine Single N06AX26 28:16 2013/10/8 　 To treat adults with major depressive disorder. 　
211 Zulresso brexanolone Single N06AX29 28:16 2019/3/26 positive allosteric modulator of GABAA receptor To treat postpartum depression (PPD) in adult women 　
212 Zurzuvae zuranolone Single N06AX31* 28:16 2023/8/4 GABAA receptor modulator To treat postpartum depression 　
213 Cobenfy xanomeline,
trospium chloride		 Combo 　 28:16 2024/9/26 muscarinic agonist, muscarinic antagonist To treat schizophrenia 　
214 Imcivree setmelanotide Single A08AA12 28:20 2020/12/1 MC4 receptor agonist To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age 　
215 Sunosi solriamfetol Single N06BA14 28:20 2019/4/9 dopamine and norepinephrine reuptake inhibitor To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea 　
216 Azstarys serdexmethylphenidate, dexmethylphenidate Combo N06BA15 28:20 2021/3/18 CNS stimulant, increasing extracellular dopamine and norepinephrine To treat attention deficit hyperactivity disorder 　
217 Wakix pitolisant Single N07XX11 28:20 2019/8/16 increases histamine synthesis and release To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy 　
218 Belviq lorcaserin hydrochloride Single 　 28:20 2012/7/16 　 For chronic weight management. 　
219 Byfavo remimazolam Single N05CD14 28:24 2020/7/7 potentiates the effect of GABA For sedation 　
220 Hetlioz tasimelteon Single N05CH03 28:24 2014/2/18 MT1 and MT2 agonist To treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. 　
221 Belsomra suvorexant Single N05CJ01 28:24 2014/8/19 OX1R and OX2R antagonist To treat difficulty in falling and staying asleep (insomnia) 　
222 Dayvigo lemborexant Single N05CJ02 28:24 2019/12/23 OX1R and OX2R inhibitor To treat insomnia 　
223 Quviviq daridorexant Single N05CJ03 28:24 2022/1/7 orexin antagonist To treat insomnia 　
224 Reyvow lasmiditan Single N02CC08 28:32 2019/11/7 5-HT receptor agonist For the acute treatment of migraine with or without aura, in adults 　
225 Aimovig erenumab-aooe Single N02CD01 28:32 2018/5/21 blocks CGRP receptor binding site and function For the preventive treatment for migraine 　
226 Emgality galcanezumab-gnlm Single N02CD02 28:32 2018/9/28 CGRP inhibitor For the preventive treatment of migraine in adults 　
227 Ajovy fremanezumab-vfrm Single N02CD03 28:32 2018/9/27 blocks CGRP ligand from binding to receptor For the preventive treatment of migraine in adults 　
228 Ubrelvy ubrogepant Single N02CD04 28:32 2020/1/21 calcitonin gene-related peptide (CGRP) antagonist To treat acute treatment of migraine with or without aura in adults 　
229 Vyepti eptinezumab-jjmr Single N02CD05 28:32 2020/2/27 CGRP ligand inhibitor For the preventive treatment of migraine in adults 　
230 Nurtec ODT rimegepant Single N02CD06 28:32 2020/3/6 CGRP receptor inhibitor To treat migraine 　
231 Qulipta atogepant Single N02CD07 28:32 2021/9/28 CGRP antagonist To prevent episodic migraines 　
232 Zavzpret zavegepant Single N02CD08* 28:32 2023/3/9 calcitonin gene-related peptide (CGRP) antagonist To treat migraine 　
233 Xadago safinamide Single N04BD03 28:36 2017/3/23 MAO-B inhibitor To treat Parkinson’s disease 　
234 Ongentys opicapone Single N04BX04 28:36 2020/5/8 COMT inhibitor To treat patients with Parkinson’s disease experiencing “off” episodes 　
235 Addyi flibanserin Single G02CX02 28:92 2015/9/2 5-HT1A agonist and 5-HT2A antagonist To treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women 　
236 Vyleesi bremelanotide Single G02CX05 28:92 2019/7/16 melanocortin receptor receptor (mechanism to improve sexual desire is unknown) To treat hypoactive sexual desire disorder in premenopausal women. 　
237 Veozah fezolinetant Single G02CX06 28:92 2023/5/12 NK3 antagonist To treat moderate to severe hot flashes caused by menopause 　
238 Nourianz istradefylline Single N04CX01 28:92 2019/10/4 A2A adenosine receptor antagonist To treat adult patients with Parkinson’s disease experiencing “off” episodes 　
239 Qelbree viloxazine Single N06AX09 28:92 2021/4/22 5-HT2B antagonist and 5-HT2B receptor agonist To treat attention deficit hyperactivity disorder 　
240 Aduhelm aducanumab-avwa Single N06DX03 28:92 2021/6/7 binding to amyloid beta protein at amino acids 3-7 To treat Alzheimer’s disease 　
241 Leqembi lecanemab-irmb Single N06DX04 28:92 2023/1/6 anti-amyloid-beta mab To treat Alzheimer’s disease 　
243 Ingrezza valbenazine Single N07XX13 28:92 2017/4/28 VMAT inhibitor To treat adults with tardive dyskinesia 　
244 Radicava edaravone Single N07XX14 28:92 2017/6/19 scavenge reactive oxygen species To treat patients with amyotrophic lateral sclerosis (ALS) 　
245 Austedo deutetrabenazine Single N07XX16 28:92 2017/4/27 depletes monoamine level For the treatment of chorea associated with Huntington’s disease 　
246 Qalsody tofersen Single N07XX22 28:92 2023/4/25 antisense oligonucleotide binding to SOD1 mRNA To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation 　
247 Daybue trofinetide Single N07XX24* 28:92 2023/3/10 insulin-like growth factor 1 (ILF-1) protein analog To treat Rett syndrome 　
248 TissueBlue Brilliant Blue G Ophthalmic Solution Single S01K 36:58 2019/12/20 selectively stains ILM but not the epiretinal membrane nor the retina Dye used in eye surgery 　
249 Macrilen macimorelin acetate Single V04CD06 36:66 2018/1/26 GH secretagogue receptor agonist For the diagnosis of adult growth hormone deficiency 　
250 Cytalux pafolacianine Single V04CX10 36:68 2021/11/29 folic acid analog conjugated with a fluorescent dye, which binds to folate receptor positive cells To help identify ovarian cancer lesions 　
251 Dotarem gadoterate meglumine Single V08CA02 36:68 2013/3/29 　 For use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older. 　
252 Lumason sulfur hexafluoride lipid microsphere Single V08DA05 36:68 2014/10/15 　 For patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves 　
253 Vizamyl flutemetamol F 18 injection Single V09AX04 36:68 2013/11/8 　 A radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia. 　
254 Neuraceq florbetaben F 18 injection Single V09AX06 36:68 2014/3/21 binds B-amyloid neuritic plaques in the brain For Positron EmissionTomography (PET) imaging of the brain 　
255 Tauvid flortaucipir F18 Single V09AX07 36:68 2020/6/15 binds to aggregated tau protein Diagnostic agent for patients with Alzheimer’s disease 　
256 Lymphoseek technetium Tc 99m tilmanocept Single V09IA09 36:68 2013/3/27 　 A radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. 　
257 fluorodopa F18 fluorodopa F18 Single V09IX05 36:68 2019/10/21 decarboxylated by amino acid decarboxylase and stored in presynaptic vesicles in the brainn A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS) 　
258 Ga-68-DOTATOC Edotreotide gallium Ga-68 Single V09IX09 36:68 2019/9/12 binds cells that express SSTR2, including malignant neuroendocrine cells For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) 　
259 Cerianna fluoroestradiol F18 Single V09IX11 36:68 2020/5/28 radiolabeled estrogen analog that binds to estrogen receptors Diagnostic imaging agent for certain patients with breast cancer 　
260 Axumin fluciclovine F 18 Single V09IX12 36:68 2016/6/28 synthetic amino acid PET imaging agent taken up by amino acid transporters upregulated in many cancer cells A new diagnostic imaging agent to detect recurrent prostate cancer 　
261 Detectnet copper Cu 64 dotatate injection Single V09IX15 36:68 2020/10/14 binds to somatostatin receptors, with high affinity for SSTR2 (overexpressed on malignant neuroendocrine cells) To help detect certain types of neuroendocrine tumors 　
262 NETSPOT gallium Ga 68 dotatate Single 　 36:68 2016/7/11 Ga68 dotatate that binds somatostatin receptors A diagnostic imaging agent to detect rare neuroendocrine tumors 　
263 Veltassa patiromer sorbitex calcium Single V03AE09 40:18 2015/10/23 binds K+ in GI tract and increases fecal K+ excretion To treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. 　
264 Lokelma sodium zirconium cyclosilicate Single V03AE10 40:18 2018/5/24 binds K+ in GI tract To treat hyperkalemia 　
265 Dojolvi triheptanoin Single A16AX17 40:20 2020/7/2 a synthetic medium chain triglyceride that provides a source of fatty acids To treat molecularly long-chain fatty acid oxidation disorders 　
266 Omegaven fish oil triglycerides Single 　 40:20 2018/8/8 beta oxidation As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis 　
267 Crysvita burosumab-twza Single M05BX05 40:92 2018/5/16 FGF23 inhibitor To treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets 　
268 Vimizim elosulfase alfa Single A16AB12 44:00 2014/2/24 exogenous enzyme N-acetylgalactosamine-6-sulfatase, increasing catabolism of GAGs KS and C6S Treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome) 　
269 Strensiq asfotase alfa Single A16AB13 44:00 2015/11/5 a human recombinant TNSALP, increasing ALP level To treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP). 　
270 Kanuma sebelipase alfa Single A16AB14 44:00 2015/12/15 catalyzes lysosomal hydrolysis of cholesteryl esters and triglycerides to free cholesterol, glycerol and free fatty acids To treat patients with a rare disease known as lysosomal acid lipase (LAL) deficiency 　
271 Lamzede velmanase alfa-tycv Single A16AB15 44:00 2023/2/16 alfa-mannosidase analog To treat non-central nervous system manifestations of alpha-mannosidosis 　
272 Brineura cerliponase alfa Single A16AB17 44:00 2017/4/28 replacement for the missing TPP1 enzyme To treat adults with tardive dyskinesia 　
273 Mepsevii vestronidase alfa-vjbk Single A16AB18 44:00 2017/12/5 exogenous source of GUS enzyme for uptake into cellular lysosomes To treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. 　
274 Palynziq pegvaliase-pqpz Single A16AB19 44:00 2018/6/13 a PEGylated PAL enzyme that converts phenylalanine to ammonia and trans-cinnamic acid To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU) 　
275 Elfabrio pegunigalsidase alfa-iwxj Single A16AB20 44:00 2023/5/9 alpha-galactosidase alfa analog To treat confirmed Fabry disease 　
276 Nexviazyme avalglucosidase alfa-ngpt Single A16AB22 44:00 2021/8/6 exerts GAA enzymatic activity to cleave glycogen To treat late-onset Pompe disease 　
277 Pombiliti cipaglucosidase alfa-atga Single A16AB23 44:00 2023/9/28 GAA analog To treat late-onset Pompe disease 　
278 Xenpozyme Olipudase alfa Single A16AB25 44:00 2022/8/31 recombinant human ASM To treat Acid Sphingomyelinase Deficiency 　
279 Revcovi elapegademase-lvlr Single L03AX21 44:00 2018/10/16 provides external source of ADA enzyme To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) 　
280 Cinqair reslizumab Single R03DX08 48:10 2016/4/11 IL-5 antagonist To treat severe asthma 　
281 Nucala mepolizumab Single R03DX09 48:10 2015/11/10 IL-5 signaling inhibitor For use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. 　
282 Fasenra benralizumab Single R03DX10 48:10 2017/11/16 IL-5 inhibitor For add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype 　
283 Orkambi lumacaftor, ivacaftor Combo R07AX30 48:14 2015/7/10 improves conformational stability of F508del-CFTR protein To treat cystic fibrosis 　
284 Symdeko tezacaftor, ivacaftor Combo R07AX31 48:14 2018/3/6 moves defective CFTR protein onto the cell surface, facilitates chloride transport on cell surface To treat cystic fibrosis in patients age 12 years and older 　
285 Trikafta elexacaftor, ivacaftor, tezacaftor Combo R07AX32 48:14 2019/11/8 increases amount and function of F508del-CFTR at the cell surface To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis 　
286 Kalydeco ivacaftor Single 　 48:14 2012/3/6 　 For the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. 　
287 Ohtuvayre ensifentrine Single 　 48:34 2024/6/26 PDE-4 and PDE-3 inhibitor To treat chronic obstructive pulmonary disease 　
288 Uptravi selexipag Single B01AC27 48:48 2016/1/28 prostacyclin receptor agonist To treat pulmonary arterial hypertension 　
289 Winrevair sotatercept-csrk Single C02KX06* 48:92 2024/3/26 activin receptor type IIA-Fc fusion protein To treat pulmonary arterial hypertension 　
290 Ofev nintedanib Single L01EX09 48:92 2014/12/3 TKI For the treatment of idiopathic pulmonary fibrosis (IPF) 　
291 Esbriet pirfenidone Single L04AX05 48:92 2014/12/17 MAP kinase inhibitor For the treatment of idiopathic pulmonary fibrosis (IPF) 　
292 Tezspire tezepelumab-ekko Single R03DX11 48:92 2021/12/17 TSLP blocker To treat severe asthma as an add-on maintenance therapy 　
293 Xdemvy lotilaner Single S01AX25* 52:04 2023/7/25 GABA-gated chloride channel inhibitor To treat Demodex blepharitis 　
294 Xtoro finafloxacin otic suspension Single 　 52:04 2014/12/19 type II, IV topoisomerase and DNA gyrase inhibitor To treat acute otitis externa, commonly known as swimmer’s ear 　
295 Xiidra lifitegrast ophthalmic solution Single S01XA25 52:08 2016/9/19 LFA-1 antagonist To treat the signs and symptoms of dry eye disease 　
296 Vyzulta latanoprostene bunod ophthalmic solution Single S01EE06 52:40 2017/11/14 a NO-donating prostaglandin F2-alpha analog that increases aqueous humour outflow To treat intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 　
297 Rhopressa netarsudil Single S01EX05 52:40 2017/12/20 Rho kinase inhibitor To treat glaucoma or ocular hypertension 　
298 Omlonti oomidenepag isopropyl ophthalmic solution Single S01EX06 52:40 2022/9/22 EP2 agonist To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension 　
299 Vabysmo faricimab-svoa Single S01LA09 52:56 2022/1/28 bispecific mab, VEGF-A and Ang-2 To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema 　
300 Tepezza teprotumumab-trbw Single L04AG13 52:92 2020/2/12 IGF-1R inhibitor To treat Thyroid eye disease 　
301 Beovu brolucizumab–dbll Single S01LA06 52:92 2019/10/10 VEGF-A inhibitor Treatment of wet age-related macular degeneration 　
302 Oxervate cenegermin-bkbj Single S01XA24 52:92 2018/8/27 recombinant nerve growth factor that targets receptors in the anterior segment of the eye To treat neurotrophic keratitis 　
303 Izervay avacincaptad pegol Single S01XA32* 52:92 2023/8/4 complement C5 protein inhibitor To treat geographic atrophy secondary to age-related macular degeneration 　
304 Miebo perfluorhexyloctane Single 　 52:92 2023/5/18 semifluorinated alkane To treat signs and symptoms of dry eye disease 　
305 Fulyzaq crofelemer Single A07XA06 56:08 2013/1/29 　 To treat HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite. 　
306 Xermelo telotristat ethyl Single A16AX15 56:08 2017/3/21 tryptophan hydroxylase inhibitor To treat carcinoid syndrome diarrhea 　
307 Pizensy lactitol Single A06AD12 56:12 2020/2/21 creates hyperosmotic environment in small intestine To treat chronic idiopathic constipation (CIC) in adults 　
308 Iqirvo elafibranor Single A05AX06 56:14 2024/6/10 PPAR agonist To treat primary biliary cholangitis in combination with ursodeoxycholic acid 　
309 Livdelzi seladelpar Single A05AX07* 56:14 2024/8/14 PPAR agonist To treat primary biliary cholangitis (PBC) 　
310 Akynzeo fosnetupitant, palonosetron Combo A04AA55 56:22 2018/5/17 5-HT3 antagonist To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy 　
311 Akynzeo netupitant, palonosetron Combo A04AA55 56:22 2014/10/15 5-HT3 antagonist (palonosetron), NK-1 antagonist (netupitant) To treat nausea and vomiting in patients undergoing cancer chemotherapy 　
312 Varubi rolapitant Single A04AD14 56:22 2015/9/17 NK-1 receptor antagonist To prevent delayed phase chemotherapy-induced nausea and vomiting (emesis) 　
313 Barhemsys amisulpride Single N05AL05 56:22 2020/3/2 D2 and D3 antagonist To help prevent nausea and vomiting after surgery 　
314 Voquezna vonoprazan, amoxicillin, and clarithromycin Combo A02BD14 56:28 2022/5/3 potassium-competitive acid blocker To treat Helicobacter pylori infection 　
315 Motegrity prucalopride Single A06AX05 56:32 2018/12/21 5-HT4 receptor agonist To treat chronic idiopathic constipation 　
316 Omvoh mirikizumab-mrkz Single L04AC24 56:44 2023/10/26 IL-23 antagonist To treat ulcerative colitis 　
317 Velsipity etrasimod Single L04AE05 56:44 2023/10/12 sphingosine 1-phosphate receptor modulator To treat moderately to severely active ulcerative colitis in adults 　
318 Entyvio vedolizumab Single L04AG05 56:44 2014/6/6 α4β7 integrin antagonist To treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease 　
319 Cholbam cholic acid Single A05AA03 56:92 2015/4/29 reduce toxic C27-bile acid intermediates and restores negative feedback loop To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders 　
320 Ocaliva obeticholic acid Single A05AA04 56:92 2016/6/1 FXR agonist To treat rare, chronic liver disease 　
321 Livmarli maralixibat Single A05AX04 56:92 2021/9/29 reversible inhibitor of IBAT To treat cholestatic pruritus associated with Alagille syndrome 　
322 Bylvay odevixibat Single A05AX05 56:92 2021/7/20 IBAT inhibitor To treat pruritus 　
323 Movantik naloxegol Single A06AH03 56:92 2014/10/10 　 To treat opioid-induced constipation in adults with chronic non-cancer pain. 　
324 Symproic naldemedine Single A06AH05 56:92 2017/3/28 opioid antagonist For the treatment of opioid-induced constipation 　
325 Trulance plecanatide Single A06AX07 56:92 2017/2/9 GC-C agonist To treat Chronic Idiopathic Constipation (CIC) in adult patients. 　
326 Ibsrela tenapanor Single A06AX08 56:92 2019/10/7 NHE3 inhibitor To treat irritable bowel syndrome with constipation in adults. 　
327 Viberzi eluxadoline Single A07DA06 56:92 2015/7/2 mu-opioid agonist and delta-opioid antagonist To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. 　
328 Rezdiffra resmetirom Single 　 56:92 2024/3/14 thyroid hormone receptor-beta (THR-β) agonist To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring 　
329 Ferriprox deferiprone Single 　 64:00 2011/11/16 binds ferric ions to form a 3:1 stable complex that’s eliminated in the urine To treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. 　
330 Emflaza deflazacort Single H02AB13 68:04 2017/2/28 corticosteroid hormone receptor agonist To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD) 　
331 Agamree vamorolone Single H02AB18 68:04 2023/10/26 glucocorticoid To treat Duchenne muscular dystrophy 　
332 Breo Ellipta fluticasone furoate, vilanterol inhalation powder Combo R03AK10 68:04

12:12		 2013/5/29 　 For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 　
333 Annovera segesterone acetate, ethinyl estradiol vaginal system Combo 　 68:12 2018/8/20 ovulation suppression New vaginal ring used to prevent pregnancy for an entire year 　
334 Duavee conjugated estrogens, bazedoxifene Combo G03CC07 68:16 2013/10/18 　 To treat moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause. 　
335 Osphena ospemifene Single G03XC05 68:16 2013/3/20 　 To treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause. 　
336 Orilissa elagolix sodium Single H01CC03 68:18 2018/7/31 GnRH antagonist For the management of moderate to severe pain associated with endometriosis 　
337 Orgovyx relugolix Single L02BX04 68:18 2020/12/23 nonpeptide GnRH antagonist To treat advanced prostate cancer 　
338 Tresiba insulin degludec injection Single A10AE06 68:20 2015/10/16 stimulate peripheral glucose uptake and control hepatic glucose production To improve blood sugar (glucose) control in adults with diabetes mellitus 　
339 Nesina alogliptin Single A10BH04 68:20 2013/2/8 　 To improve blood sugar control in adults with type 2 diabetes. 　
340 Adlyxin lixisenatide Single A10BJ03 68:20 2016/10/19 GLP-1 agonist To improve glycemic control (blood sugar levels) 　
341 Tanzeum albiglutide Single A10BJ04 68:20 2014/4/23 GLP-1 agonist To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes 　
342 Trulicity dulaglutide Single A10BJ05 68:20 2014/10/10 　 To treat adults with type 2 diabetes. 　
343 Ozempic semaglutide Single A10BJ06 68:20 2017/12/18 GLP-1 receptor agonist To improve glycemic control in adults with type 2 diabetes mellitus 　
344 Farxiga dapaglifozin Single A10BK01 68:20 2014/2/14 SGLT2 inhibitor To improve glycemic control, along with diet and exercise, in adults with type 2 diabetes 　
345 Invokana canagliflozin Single A10BK02 68:20 2013/5/15 　 Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. 　
346 Jardiance empagliflozin Single A10BK03 68:20 2014/8/13 SGLT-2 inhibitor To improve gylcemic control in adults with type 2 diabetes 　
347 Steglatro ertugliflozin Single A10BK04 68:20 2017/12/21 SGLT2 inhibitor To improve glycemic control in adults with type 2 diabetes mellitus 　
348 Mounjaro tirzepatide Single A10BX16 68:20 2022/5/13 GIP and GLP-1 agonist To improve blood sugar control in diabetes, in addition to diet and exercise 　
349 Tzield teplizumab-mzwv Single A10XX01 68:20 2022/11/18 mab, CD3 To delay the onset of stage 3 type 1 diabetes 　
350 Tradjenta linagliptin Single 　 68:20 2011/5/2 DPP-4 inhibitor An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 　
351 Zegalogue dasiglucagon Single H04AA02 68:22 2021/4/15 hepatic glucagon receptor agonsit To treat severe hypoglycemia 　
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