Browse the FDA Approved Drugs by Year
Browse 2021 FDA Approved Drugs by Month
August
Difelikefalin
Difelikefalin is a kappa-opioid receptor agonist(acts as an opioid) approved for treating moderate-to-severe pruritus (itching) linked to long-term kidney disease in adults undergoing hemodialysis. The recommended dosage is 0.5 mcg/kg body wt. It should be given as an intravenous bolus injection(giving through one vein at a time). Patients may get dizziness, somnolence(increased sleepiness), Mental Status Changes, and Gait Disturbances. Patients should be careful during driving. -The most common side effects include diarrhea, dizziness, nausea, gait disturbances, etc.
January
Cabotegravir and rilpivirine combination
The U.S. Food and Drug Administration approved Cabenuva(trade name)for the treatment of human immunodeficiency virus type 1 (HIV-1) infection
Vericiguat
VERQUVO, the brand name of Vericiguat helps to reduce the risk of dying and hospitalization in patients with chronic heart failure. It is a tablet that is taken by mouth once a day.
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Voclosporin
To treat lupus nephritis(kidney disease that occurs in lupus disorder) It is approved under the brand name Lupkynis It is a capsule that is taken twice daily by mouth in combination with two other drugs (mycophenolate mofetil and corticosteroid).
June
Ibrexafungerp
To treat vulvovaginal(genital) candidiasis(fungal infection) in adult females and pediatric females who started menstruating It is available as tablet. Approved under the trade name Brexafemme
February
Casimersen
The U.S. Food and Drug Administration granted approval for Casimersen for treating a muscle disorder called Duchenne muscular dystrophy (DMD) in patients with mutation related to exon. The most common side effects observed in clinical trials were upper respiratory tract infections, cough, fever, headache, joint pain and throat pain.
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Evinacumab
Evinacumab injection is approved as an adjunct to other cholesterol-reducing therapies for treating patients aged above 12 years with homozygous familial hypercholesterolemia (HoFH). The recommended dose is 15 mg/kg administered by intravenous (IV) infusion once monthly.
Fosdenopterin
The U.S. Food and Drug Administration approved Fosdenopterin under the trade name "Nulibry" injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A. It is a rare, genetic, metabolic disorder that presents in the first few days of life, causing fits, brain injury and death. The most common side effects included complications related to the intravenous line, fever, respiratory infections, vomiting, gastroenteritis, and diarrhea.
Melphalan flufenamide
Melphalan flufenamide is approved by the USFDA for treating cancer named multiple myeloma patients who have received four prior lines of therapy and whose disease is resistant to other chemotherapeutic agents. The recommended dose is 40 mg intravenously over 30 minutes on Day one of 28-day treatment cycle along with dexamethasone. Dosage form for injection: 20 mg melphalan flufenamide for reconstitution.
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Trilaciclib
Trilaciclib was approved by the USFDA to reduce the frequency of chemotherapy-induced bone marrow depression in adults receiving chemotherapy for cancer. The most common side effects include tiredness, low levels of calcium, potassium and phosphate; increased levels of enzyme named aminotransferase, headache; and infection in the lungs (pneumonia).
Tepotinib
Tepotinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). It is available as 225mg tablet side effects include edema, tiredness and nausea.
March
Dasiglucagon
Dasiglucagon is approved under the trade name ZEGALOGUE. It is an antihypoglycemic agent used for tearing severe hypoglycemia(low blood glucose) in patients aged above 6 years. It is injected into fatty layer of skin(subcutaneous) of either lower abdomen or buttocks or thigh or outer upper arm. Oral carbohydrates can be given once the patient responds to treatment. Patients with Pheochromocytoma and Insulinoma should not use dasiglucagon The most common side effects include nausea, vomiting, headache, diarrhea, and injection site pain
Ponesimod
Ponesimod is approved under the trade name "PONVORY" for treating multiple sclerosis (MS) in adults. The recommended maintenance dosage is 20 mg taken orally once daily Dosage forms: Tablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mg. The drug should not be used for patients who had a heart attack, stroke, heart failure requiring hospitalization in the last six months. The most common side effects include upper respiratory tract infection, liver problems, and hypertension.
Serdexmethylphenidate and dexmethylphenidate
Serdexmethylphenidate and dexmethylphenidate combination is approved on March 2-21 for treating Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. The recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. The maximum recommended dosage is 52.3 mg/10.4 mg once daily. Serdexmethylphenidate and dexmethylphenidate combination is available as capsules: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg.
Tivozanib
The USFDA approved Tivozanib under the trade name "FOTIVDA" for treating adults with relapsed or refractory advanced renal cell carcinoma (RCC). The recommended dose is 1.34 mg once daily with or without food for 21 days followed by 7 days off treatment. Tivozanib is available as capsules: 1.34 mg and 0.89 mg to be taken by mouth. The most common side effects are tiredness, hypertension, diarrhea, decreased appetite, nausea, hypothyroidism, cough, etc.
Umbralisib
Umbralisib is approved for treating adults with cancers like marginal zone lymphoma (MZL), follicular lymphoma (FL) who have received at least three previous systemic therapies. The recommended dose is 800 mg orally once daily with food Patients should be monitored for fever and any new or worsening signs and symptoms of infection.
April
Dostarlimab
Dostarlimab is approved by the USFDA during April 2021 under the trade name "JEMPERLI" for treating adults with repeated or advanced endometrial cancer(cancer of the lining of the uterus). Females of reproductive potential should use effective contraception as the drug may cause fetal harm. The dose is 500mg injection into the vein every week. The most common side effects include tiredness, nausea, diarrhea, anemia, and constipation.
Drospirenone and Estetrol
Drospirenone and Estetrol combination is approved under the trade name "NEXTSTELLIS" for preventing pregnancy in females of reproductive potential. The combination could be less effective in females with a BMI ≥ of 30 kg/m2 Dosage: One tablet by mouth every day at the same time. The combination should not be used by patients with a high risk of arterial or venous clots, Current or history of hormonal cancers, certain liver disorders, renal failure. The most common adverse reactions include irregular bleeding, mood disturbances, headache, breast symptoms, pain during menses, etc.
Loncastuximab
Loncastuximab tesirine-lpy is approved for treating adults with relapsed or refractory lymphomas(a kind of cancer involving the lymphatic system). The medication is given as an intravenous infusion over 30 minutes on Day 1 of each cycle (every 3 weeks). The patient should receive dexamethasone 4 mg for 3 days before starting treatment with Loncastuximab. The most common side effects reported in clinical trials are low platelet count, increased liver enzymes, low WBC count, low hemoglobin, increased glucose levels, etc.
Viloxazine
Viloxazine is approved for treating Attention Deficit Hyperactivity Disorder (ADHD) in kids aged 6 to 17 years. The medication is available as extended-release capsules: 100 mg, 150 mg and 200 mg The recommended starting dosage is 100 mg once daily. The dose may be increased after 1 week. In patients with severe kidney problems, the initial dosage is 100 mg once daily. Assess heart rate and blood pressure prior to initiating treatment. Mania may get activated. So screen patients for bipolar disorder. Patients should be careful while driving or operating heavy machinery while using this medication.
May
Amivantamab
Amivantamab injection has to be given into the vein for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This indication is approved under accelerated approval based on overall The recommended dosage is based on baseline body weight. Infusion-related reactions can occur. The most common side effects are rash, musculoskeletal pain, breathing issues, tiredness, nausea, fatigue, fluid accumulation, vomiting, etc.
Infigratinib
To treat adults with cholangiocarcinoma (cancer of bile duct) whose disease meets certain criteria. Approved under the trade name Truseltiq. This should be taken as a 125 mg capsule orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles. It should be taken on an empty stomach at least 1 hour before or 2 hours after food, at the same time every day. The most common side effects include nail toxicity, stomatitis(swelling of mucous membranes of the mouth), dry eye, tiredness, hair fall, joint pain, taste disturbances, dysgeusia, abdominal pain, eyelash changes, etc.
Olanzapine and samidorphan
Olanzapine and samidorphan combination is approved for treating schizophrenia and bipolar disorder(mood swings) in adults and for the treatment of acute mania. The initial starting dosage is 5 mg/10 mg once daily. This combination is available as tablets with doses: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg. The combination should not be used by patients using opioids, patients undergoing acute opioid withdrawal. The most common side effects include weight gain, increased sleep, dry mouth, and headache. It is approved under the trade name "Lybalvi"
Pegcetacoplan
The USFDA approved Pegcetacoplan for treating adults with paroxysmal nocturnal hemoglobinuria (PNH). The dosage is 1,080 mg by subcutaneous infusion(injecting into the fatty layer of skin) twice weekly through a pump. The medication should not be given to patients with allergies to pegcetacoplan or any of the components, patients who are not vaccinated against certain bacteria, and patients with unresolved serious infection caused by encapsulated bacteria. The most common side effects reported are injection-site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, viral infection, and fatigue.
Piflufolastat
Piflufolastat is approved under the trade name "PYLARIFY" which is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The dose is 333 MBq (range: 296 MBq to 370 MBq), administered as a bolus intravenous injection(at a time into the vein). The patient should void immediately prior to the initiation of imaging. Imaging should be done 1 hour after administration of this drug. Patients should be monitored for allergic reactions and proper handling should be ensured to protect from radiation.
Sotorasib
Sotorasib is used to treat adults with non-small cell lung cancer whose disease meets certain criteria. US FDA approved the drug under the trade name "Lumakras" The recommended dosage is 960 mg orally one tablet daily The most common side effects reported were diarrhea, musculoskeletal pain, nausea, fatigue, liver problems, and cough. The most common lab abnormalities were decreased WBC, decreased hemoglobin, increased liver enzymes, decreased calcium, decreased sodium, etc. Avoid taking this medication with antacids. If an acid-reducing agent cannot be avoided, administer this drug 4 hours before or 10 hours after antacid.
June
Aducanumab
Aducanumab was approved by the USFDA for treating Alzheimer’s disease. The drug reduces amyloid-beta plaques deposition. The drug should be injected into the vein and the recommended maintenance dosage is 10 mg/kg body weight over one hour every four weeks. The medication is available as 170 mg/1.7 mL solution and 300 mg/3 mL solution in a single-dose vial. Before starting this medication, a recent MRI should be obtained. The medication may cause amyloid Related Imaging Abnormalities (ARIA), especially during the first 8 doses of treatment. The most common side effects include ARIA-Edema(fluid accumulation), headache, etc.
Asparaginase Erwinia Chrysanthemi(Recombinant)
Asparaginase Erwinia Chrysanthemi(Recombinant) was approved in June 2021 by the USFDA under the trade name "RYLAZETM" as a part of the chemotherapeutic regimen for treating blood cancers like acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and kids aged 1 month and above. The drug should be injected into the muscle every 48 hours. The medication should not be used in patients with a history of: • Serious allergic reactions including anaphylaxis. • Serious pancreas problems during previous L-asparaginase therapy • Serious blood clot formations and bleeding disorders. The most common side effects include nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia(fever), drug allergy, febrile neutropenia(low WBC count), decreased appetite, stomatitis(swelling of mucous membranes of the mouth), bleeding, and hyperglycemia(excess blood glucose).
Ibrexafungerp
Ibrexafungerp is an antifungal approved for treating adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC). The medication is available as 150mg tablets The dosage is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. The medication should not be taken by pregnant women and those with allergic reactions to ibrexafungerp. Females of reproductive potential should use effective contraception during treatment. The most common side effects reported were diarrhea, nausea, abdominal pain, dizziness, and vomiting. •This medication should not be used along with enzyme inducers or inhibitors(drugs that modify liver metabolism).
July
Anifrolumab
Anifrolumab is approved by the USFDA under the trade name "SAPHNELO" indicated for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE). The recommended dosage is 300 mg as an intravenous infusion(injected into the vein)for 30minutes every 4 weeks. Dosage form: Injection: 300 mg/2 mL (150 mg/mL) Patients who receive this therapy may experience serious infections, including the respiratory infections and herpes zoster. The individual benefit-risk ratio should be calculated before starting the therapy for cancer patients and patients with active infections. Avoid the use of live or live-attenuated vaccines in patients taking anifrolumab. The most common side effects seen with this medication are nasopharyngitis(swelling of nose, throat), bronchitis(swelling of airways), infusion related reactions, herpes zoster and cough.
Belumosudil
Belumosudil is a kinase inhibitor approved for treating adults and kids aged above 12 years with chronic graft-versus-host disease (GVHD) after the failure of at least two prior lines of systemic therapy Recommended Dosage: 200 mg tablet taken by mouth once daily with food. The drug may cause embryo-fetal toxicity. So, patients should use effective contraception If the patient is using any of the strong CYP3A Inducers or proton pump inhibitors, the dose of Belumosudil should be increased to 200 mg twice daily. The most common side effects seen include infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, etc.
Fexinidazole
Fexinidazole Tablets is an antimicrobial, approved for treating first-stage and second-stage human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients aged above 6 years and weighing at least 20 kg. Dosage: Administer 600mg Fexinidazole Tablets once daily with food. This medication should not be used for patients with known allergy to medication and liver disease. Some patients may experience QT Interval Prolongation(heart rhythm abnormalities), agitation, anxiety, abnormal behavior, depression, suicidal ideation, nightmares, hallucination. Monitor patients with low WBC count for any signs of infection. The most common side effects are headache, vomiting, insomnia(lack of sleep), nausea, asthenia, tremor, decreased appetite, dizziness, low calcium level, acidity, back pain, upper abdominal pain, and hyperkalemia.
Finerenone
The USFDA approved Finerenone in July 2021 to reduce the risk of end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.- The recommended initial dosage is 10 mg or 20 mg orally once daily. Dosage can be increased after 4 weeks to the target dose of 20 mg once daily based on eGFR and serum potassium thresholds. Dosage form: Tablets: 10 mg and 20 mg. Patients with adrenal insufficiency should not use this medication. The most common side effects occurring in ≥ 1% of patients are hyperkalemia(increased potassium levels), hypotension(low blood pressure), and hyponatremia(low sodium levels).
Odevixibat
US FDA approved Odevixibat capsules or orall pellets for the treatment of itching in patients aged above 3 months with progressive familial intrahepatic cholestasis(PFIC) type 1. But, this drug may not be effective in PFIC type 2 patients with variants leading to the non-functional or complete absence of bile salt The recommended dosage is 40 mcg/kg once daily in the morning with a meal. The dosage may be increased up to 120 mcg/kg once daily if there is no improvement. DOSAGE FORMS AND STRENGTHS: Oral Pellets: 200 mcg, 600 mcg (3) Capsules: 400 mcg, 1200 mcg (3)
August
Avalglucosidase alfa
Avalglucosidase alfa is approved under the trade name "NEXVIAZYME". It is a hydrolytic lysosomal glycogen-specific enzyme indicated for treating patients aged 1 year and older with late-onset Pompe disease (alpha-glucosidase [GAA] deficiency). The drug is administered as an intravenous infusion(given into the vein). The dose depends on the body weight. If the patients' body weight is <30 kg, the recommended dosage is 40 mg/kg (of actual body weight) every two weeks. The most common side effects seen in clinical trial patients were headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, and urticaria.
Belzutifan
Belzutifan is indicated for treating adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. It is available as tablets, for oral use Exposure to this drug during pregnancy can cause embryo-fetal harm. So, pregnancy status should be verified prior to the initiation of treatment. The recommended dosage is 120 mg administered orally(to be taken by mouth) once daily with or without food Available dose of¬ tablets: 40 mg
Lonapegsomatropin
Lonapegsomatropin is a human growth hormone approved by the FDA for the treatment of pediatric patients aged above who weigh at least 11.5 kg and have growth failure due to improper secretion of growth hormone. The drug should be administered subcutaneously(into the fatty layer of skin) into the abdomen, buttock, or thigh. The recommended dose is 0.24 mg/kg body weight once-weekly It should not be used for patients with acute critical illness, allergy to somatropin or any of the excipients, kids with closed epiphysis, active cancers, active proliferative or severe non-proliferative diabetic retinopathy, etc. The most common side effects include viral infection, fever, cough, nausea, and vomiting, etc.
September
Atogepant
Atogipant has been approved for the preventive treatment of migraine in adults. The recommended dosage is 10 mg, 30 mg, or 60 mg taken orally once daily with or without food depending on the patient's symptoms. The dose is 10 mg once a day in case of kidney problems. Common side effects include nausea, constipation, and fatigue. This medicine should not be used by pregnant women and patients with liver disorders.
Maralixibat
The USFDA approved maralixibat under the trade name LIVMARLI. It is a bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus(itching due to jaundice) in patients with Alagille syndrome aged above 1 year. Dosage: The initial dose is 190 mcg/kg orally once daily and should be increased to 380 mcg/kg once daily after one week The most common side effects reported in clinical trials are diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, gastrointestinal bleeding, and bone fractures, etc. Liver function tests should be done before starting the treatment with maralixibat.
Mobocertinib
Mobocertinib is approved for the treatment of adults with lung cancer with certain mutations. It should be tested by an FDA-approved test before giving the medication. This medicine is available as a 40mg capsule. The recommended dosage is 160mg daily once. The most common side effects found in clinical trials are diarrhea, rash, nausea, vomiting, decreased appetite, paronychia, tiredness, etc. Caution is required in patients with lung disorders, heart disorders, and diarrhea.
Tisotumab
Tisotumab is indicated for treating adults with recurrent or metastatic cervical cancer. The medication is given as an intravenous infusion only. The recommended dose is 2 mg/kg over 30 minutes every 3 weeks. Caution is required in patients with nerve problems, bleeding disorders, pneumonia. This medication is not indicated for pregnant and lactating women. The most common side effects include tiredness, low blood counts, hair fall, dry eye etc.
October
Asciminib
Asciminib was approved by the USFDA under the trade name "scemblix" to treat Philadelphia chromosome-positive chronic myeloid leukemia with a disease. chronic myeloid leukemia is a kind of blood cancer. The medication is available as 20mg and 40mg tablets The recommended dosage is 80 mg orally once daily or 40 mg twice daily. Avoid food for at least 2 hours before and 1 hour after taking Asciminib. Side effects include upper respiratory tract infections, rash, diarrhea, musculoskeletal pain, fatigue, nausea, etc.
Avacopan
Avacopan was approved under the trade name "TAVNEOS" for the treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (a disorder of blood vessel) in combination with glucocorticoids. It is available as a capsule The recommended dosage is 30 mg twice daily, with food. Patients with liver problems and allergic reactions should be careful while using this drug.
November
Marbavir
Maribavir was approved under the trade name "LIVTENCITY" It is used for treating infections caused by cytomegalovirus for the treatment of adults and pediatric patients aged above 12 years Dosage: 400 mg orally twice daily with or without food. This medication is available as 200mg tablets
Pafolacianine
Pafolacianine was approved under the trade name "CYTALUX" It is indicated for ovarian cancer. The recommended dosage is 0.025 mg/kg administered intravenously over 60 minutes 1 hour to 9 hours prior to surgery. It can cause nausea, vomiting, abdominal pain and flushing
Ropeginterferon
The U.S. Food and Drug Administration approved Ropeginterferon alfa-2b injection under the trade name "Besremi" to treat adults with polycythemia vera. Polycythemia vera is a blood disease that causes excess production of red blood cells. It is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history. The drug is an injectable Dose: 500mcg/ml It should be injected into fatty layer of skin
Vosoritide
Vosoritide was approved by the USFDA to improve growth in children five years of age and older with achondroplasia and open epiphyses. Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth. Common side effects include injection site reactions, vomiting and decreased blood pressure. Voxzogo’s labeling also lists decreased blood pressure as a warning and precaution, which means it is a potentially serious side effect. The drug should be injected into fatty layer of skin
December
Efgartigimod
Efgartigimod was approved under the trade name "VYVGART" It is used for the treatment of generalized myasthenia gravis in adults. The recommended dosage is 10 mg/kg administered as an IV infusion over one hour once weekly for 4 weeks. The drug can cause respiratory tract infections and urinary tract infections
Inclisiran
Inclisiran was approved by the USFDA to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The recommended dosage of LEQVIO, in combination with maximally tolerated statin therapy, is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months. Common side effects include injection site reaction, arthralgia etc.
Tezepelumab
Tezepelumab was approved under the trade name TEZSPIRE It is approved as an add-on maintenance treatment for adults and kids aged 12 years above with severe asthma. It is not useful for providing relief of acute bronchospasm or status asthmaticus.
Tralokinumab
Tralokinumab was approved to treat moderate-to-severe atopic dermatitis Atopic dermatitis is a disorder of the skin, in which skin bumps with itching and swelling were seen throughout the body.
