FDA Approved Drugs in 2020

January

Avapritinib

The US FDA approved Avapritinib under the trade name AYVAKIT for treating adults with gastrointestinal stromal tumors (GIST) that are metastatic in nature(spreads to other body parts). Dosage form: Tablets: 100 mg, 200 mg and 300 mg The recommended daily dose is 300 mg orally once daily one hour before and two hours after a meal- on an empty stomach withhold Avapritinib for Grade 1 or 2 intracranial hemorrhage(bleeding inside the cranium) Common side effects reported are edema, nausea, fatigue/asthenia, cognitive impairment, etc.

TAZEMETOSTAT

The US FDA approved TAZEMETOSTAT for treating patients aged above 16 years with metastatic or locally advanced epithelioid sarcoma who cant undergo complete resection. It should be taken as 800 mg taken orally twice daily with or without food. It can increase the risk of developing secondary cancers like lymphoma, leukemia, etc. It can cause fetal harm. So, patients should use effective non-hormonal contraception. Common side effects reported with TAZEMETOSTAT are pain, fatigue, nausea, decreased appetite, vomiting etc.

TEPROTUMUMAB

The US FDA approved TEPROTUMUMAB under the trade name TEPEZZA for treating thyroid eye disease. It should be given by intravenous infusion. Start with 10 mg/kg for the first infusion, followed by 20 mg/kg every 3 weeks for 7 additional infusions over around one hour. Stop or slow the rate of infusion in case of any infusion reactions. The patient's glucose levels should be monitored regularly while taking TEPROTUMUMAB. Common side effects reported are muscle spasms, nausea, alopecia, diarrhea, fatigue, hyperglycemia, etc. Effective contraception should be used before starting the therapy, during and for 6 months following the last dose of TEPROTUMUMAB.

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July

Remimazolam

The US FDA approved Remimazolam under the trade name BYFAVO for inducing and maintaining sedation in adults undergoing procedures that last 30 minutes or less. It is given as 5 mg push injection by intravenous route over 1-minute time. Patients who are having an allergy to dextran 40 should not use Remimazolam. Common side effects reported are blood pressure variations like diastolic hypertension, systolic hypertension, hypoxia(low oxygen levels) and diastolic hypotension.

February

Amisulpride

The US FDA approved Amisulpride under the trade name BARHEMSYS for preventing nausea and vomitings after a surgery. It is given as 5 mg by the intravenous route for 1-2 min before surgery. It may cause OT prolongation(abnormal heart finding in ECG). Patients with heart disorders or electrolyte abnormalities should not use Amisulpride. Common side effects reported are increases prolactin levels, low potassium levels, hypotension or fall in blood pressure, infusion site pain, etc.

Bempedoic acid

The USFDA has approved Bempedoic acid under the trade name NEXLETOL as an adjunct to diet and maximally tolerated cholesterol-lowering statin therapy for treating adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require lowering of bad cholesterol of LDL-C. The medication is available as a 180 mg tablet to be taken orally once daily with or without food. Patients with hyperuricemia should check their uric acid levels regularly. Common side effects reported are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, etc.

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Eptinezumab

The USFDA approved Eptinezumab under the trade name Vyepti For preventing migraine in adults. The medication is available as an intravenous injection which must be diluted before use The dosage should be 100 mg as an intravenous infusion over around 30 minutes every 3 months. It should not be used in patients with a serious allergy to eptinezumab or to any of the excipients Common adverse reactions reported with the medication in clinical trials are nasopharyngitis and hypersensitivity( angioedema, urticaria, facial flushing, and rash), etc.

Lactitol

The US FDA approved Lactitol under the trade name PIZENSY It is an osmotic laxative used for treating adults with chronic idiopathic constipation The recommended daily dosage is 20 grams orally. Common side effects observed are upper respiratory tract infection, flatulence, diarrhea, increased blood creatinine, etc. The drug should not be used in patients with intestinal obstruction and galactosemia (a disorder in which body abnormally processes simple sugar called galactose).

RIMEGEPANT

Rimegepant was approved under the trade name NURTEC ODT. It is used for sudden, severe migraine with or without aura in adults. Dose: The recommended dose is 75 mg taken orally, as needed Dosage form: orally disintegrating tablets. Discontinue the medication if a serious hypersensitivity reaction occurs, Severe allergic reactions include dyspnea and rash. Common side effect reported in ≥ 1% of patients is nausea.

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March

Isatuximab

The U.S. Food and Drug Administration approved Isatuximab-irfc under the trade name Sarclisa, to be used along with pomalidomide and dexamethasone, for treating adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Dosage form: The drug is administered through intravenous (IV) infusion. It acts by helping certain cells in the immune system attack multiple myeloma cancer cells. Common adverse effects seen in patients taking Isatuximab were neutropenia (low white blood cells), infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, etc. Women who are pregnant should not use this medication. Women planning to become pregnant should use a proper contraceptive during and for at least five months after treatment.

Osilodrostat

The U.S. Food and Drug Administration approved Osilodrostat under the trade name Isturisa for treating adult patients with Cushing’s disease who can't undergo pituitary surgery or have undergone the surgery but still have the disease. This is the first FDA-approved drug to directly address the overproduction of cortisol. It acts by blocking the 11-beta-hydroxylase enzyme. Dosage form: oral tablet 2-30mg once or twice a day depending on the patient's condition. Healthcare providers may re-evaluate dosage, depending upon the patient’s response. Common adverse effects reported were adrenal insufficiency, headache, vomiting, nausea, fatigue, and edema (swelling caused by fluid retention).

Ozanimod

The US FDA has approved Ozanimod under the trade name ZEPOSIA to treat adult patients with multiple sclerosis. Dosage form: Capsules containing 0.23 mg, 0.46 mg, 0.92 mg of medication, to be taken orally. If a dose is missed within the first 2 weeks of treatment, start the treatment again with the titration regimen. Ozanimod should not be used for patients who have a heart attack, unstable angina, stroke, transient ischemic attack, etc in the last 6 months. The medication may increase the chance of infections, liver injury. Common side effects reported in clinical trials with the use of this medication include upper respiratory infection, urinary tract infection, back pain, and hypertension, etc.

April

Opicapone

The US FDA approved Opicapone under the trade name 'ONGENTYS', to be used as adjunctive treatment to levodopa/carbidopa in Parkinson's patients who experience “off” episodes frequently. The drug is available as 25mg and 50 mg capsules. The recommended dosage is 50 mg administered orally, once daily at bedtime 1 hour before taking food. The medication should not be used in patients with a history of pheochromocytoma, paraganglioma. Common side effects reported in clinical trials are dyskinesia, constipation, hypotension(low blood pressure), and decreased weight.

PEMIGATINIB

The US FDA approved PEMIGATINIB under the trade name PEMAZYRE for adults with a type of inoperable locally advanced cholangiocarcinoma(bile duct cancer). Pregnant, breastfeeding women, patients with excess phosphate levels should not use PEMIGATINIB. Common side effects reported are increases phosphate levels, hair loss, diarrhea, nail toxicity, tiredness, joint pains, etc. Dosage: The recommended dose is 13.5 mg orally once daily for 14 days followed by 7 days off therapy in 21-day cycles.

Sacituzumab

The Food and Drug Administration granted approval to Sacituzumab govitecan-hziy Under the trade name TRODELVY to treat adults with metastatic triple-negative breast cancer who received at least two therapies for the metastatic disease before. Common side effects reported with this drug are nausea, neutropenia(low white blood cell count), diarrhea, fatigue(tiredness), vomiting, alopecia(hair loss) etc. The recommended dose is 10 mg/kg given by intravenous infusion on days 1 and 8 every 21 days until disease progression or unacceptable toxicity.

Selumetinib

The US FDA approved Selumetinib under the trade name KOSELUGO to treat children aged above 2 years with plexiform neurofibroma or PN tumor that occurs in a rare disease called neurofibromatosis type 1 (NF1). It is used in patients whose tumors cause various symptoms but could not be removed surgically. Dosage: Selumetinib is available in the form of a capsule to be taken two times a day. Side effects: Selumetinib may weaken the heart, cause eye problems including loss of sight, diarrhea, and skin rashes.

Tucatinib

The US FDA approved Tucatinib under the trade name Tukysa for treating women with inoperable or metastatic(spread to distant places) HER2-positive breast cancer. Dosage: Tucatinib is available as 50mg tablet, to be taken orally. The recommended dosage is 300 mg twice daily with or without food. Common side effects reported in clinical trials are diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, etc. Patients should use effective contraception as the drug may cause harm to developing babies.

June

Triheptanoin

The US FDA approved Triiheptanoin under the trade name DOJOLVI as a source of calories and fatty acids for treating children and adults with molecularly confirmed long-chain fatty acid oxidation disorders. Dosage form: Oral Liquid, 100% w/w of triheptanoin We have to frequently monitor the tube to ensure proper functioning and integrity. Common side effects include abdominal pain, diarrhea, vomiting, and nausea.

July

Abametapir

The US FDA approved Abametapir under the trade name XEGLYZE for treating treat head lice in patients aged above 6 months. Dosage form: It is a lotion applied once to dry hair. The drug contains benzyl alcohol that may cause serious injury if taken accidentally or used in patients younger than 6 months. Common adverse effects caused by the drug include skin redness, rash, skin burning sensation, skin inflammation, vomiting, eye irritation, skin itching, and hair color changes.

Decitabine and Cedazuridine

The US FDA approved Decitabine and Cedazuridine under the trade name INQOVI for treating adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia, a kind of blood cancer. Dosage form: The drug is available as a tablet to be taken once a day on Days 1 through 5 of each 28-day cycle. The drug can cause serious and life-threatening bone marrow suppression. Common adverse effects caused by the drug are low cell counts, tiredness, constipation, bleeding, muscle pain, joint pain, nausea, shortness of breath, diarrhea, rash, dizziness, febrile neutropenia, swelling of arms or legs, and headache. The drug's safety and efficacy are evidenced by two clinical trials on 213 patients with MDS or chronic myelomonocytic leukemia.

Fostemsavir

The U.S. Food and Drug Administration approved Fostemsavir under the trade name Rukobia. It is an antiretroviral medication to be used for adults living with HIV who have tried various HIV drugs and whose HIV infection cannot be successfully treated with other therapies because of resistance. The medication has be to taken twice daily by mouth. The most common side effect reported is nausea. Severe side effects include elevations in liver enzymes among patients also infected with the hepatitis B or C virus.

Tafasitamab

Tafasitamab was approved under the trade name MONJUVI to treat adults with diffuse large B-cell lymphoma (DLBCL) whose disease has come back or has not improved after previous treatments. The drug is given by a healthcare provider directly into the bloodstream into the vein. The drug may cause side effects like infusion-related reactions, bone marrow suppression, infections. Common side effects caused by the drug include low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.

August

Belantamab

The US FDA approved Belantamab under the trade name BLENREP for treating blood cancer named multiple myeloma. It is to be used in patients who did not respond to at least four previous treatments. The drug is given directly into the vein as an I.V. infusion by a healthcare provider every three weeks. The drug may cause serious changes to the cornea that can worsen vision and leads to vision loss. Common side effects caused by the drug include corneal changes, decreased vision or blurred vision, nausea, low blood cell counts, fever, infusion-related reactions, tiredness.

Clascoterone

The US FDA has approved Clascoterone under the trade name 'Winlevi' on 26 Aug 2020 for treating Acne for patients aged above 12 years. It is an anti-androgen medication, available as a 1% cream to be applied locally. Each gram of cream contains 10mg of clascoterone as an active ingredient. It should be applied on the affected area during morning and evening. Avoid contact with eyes or mouth or mucus membranes. The cream may produce reddening, local irritation, itching or peeling of skin rarely. Kids are more prone to systemic(whole-body) reactions. Potassium levels may increase in rare cases.

Nifurtimox

The US FDA approved Nifurtimox under the trade name LAMPIT for treating children less than 18 years of age suffering from Chagas disease. Nifurtimox is available as a tablet. It is taken by mouth three times a day with food for 60 days. Total daily dose is assessed depending on the child's weight. The drug may cause serious effects like worsening of neurologic and mental conditions, severe allergic reactions, weight loss. The drug may harm the developing fetus when taken by pregnant women

Oliceridine

The U.S. Food and Drug Administration approved Olinvyk (the active component is oliceridine), for managing moderate to severe acute pain in adults. It is used only when the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate. The drug is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures. Common adverse effects caused by the medication are nausea, vomiting, dizziness, headache and constipation. It should not be given to patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.

Risdiplam

The U.S. Food and Drug Administration grnated approval for Evrysdi (risdiplam is the active component) for treating patients two months of age and older with spinal muscular atrophy (SMA). This is the second drug and the first oral drug approved to treat this disease. Common adverse effects caused by the drug include fever, diarrhea, rash, ulcers of the mouth area, joint pain (arthralgia) and urinary tract infections.

Satralizumab

The U.S. Food and Drug Administration has approved satralizumab-mwge under the trade name Enspryng for treating neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. The effectiveness and safety of Enspryng for the treatment of NMOSD was demonstrated in two 96-week clinical studies. There is a chance of an icreased risk of infection, including serious and potentially fatal infections – such as potential reactivation of hepatitis B and tuberculosis.

Somapacitan

Somapacitan is used as a replacement of growth hormone in adults with growth hormone deficiency (GHD), where body doesn’t produce enough growth hormone. The medication is available as an injection to be given under the skin (subcutaneously) once every week. It helps to decrease truncal fat percentage also. Warnings: The drug can increase the risk of cancer that is already present and increased the risk of the return of cancer, or increase blood sugar levels. Adverse effects: The drug can cause back pain, joint pain, indigestion, sleep problems, dizziness, tonsillitis, swelling of the extremities, vomiting, decreased adrenal gland function, increased blood pressure etc.

Viltolarsen

The US FDA approved Viltolarsen under the trade name 'Viltepso' for treating patients with Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene. The drug's safety was evaluated in two clinical studies with a total of 32 patients, all of whom were male and had genetically confirmed DMD. Common adverse effects observed in DMD patients with 80 mg/kg once a week include Upper respiratory tract infection, injection site reaction, cough, and fever.

September

Copper dotatate

Copper dotatate is used for detecting a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs) in adults. Dosage: The drug is injected into a vein in preparation for an imaging test called positron emission tomography scan or PET scan to help detect the tumor. It is a radioactive drug that can increase the risk of radiation exposure. Side effects: The drug can cause nausea, vomiting, and flushing.

Pralsetinib

Pralsetinib is used for treating non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) and is caused by abnormal RET genes among adults. It is available as a capsule. Dose: Four capsules (400 mg) have to be taken by mouth once a day on an empty stomach. The medication was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug. Side effects: The drug can cause lung inflammation(swelling), increased blood pressure, liver toxicity, bleeding, impaired wound healing, and harm to an unborn baby.

November

Lonafarnib

The U.S. Food and Drug Administration approved lonafarnib under the trade name Zokinvy ( for decreasing the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older. The drug is available as a capsule, to be taken orally. The most common side effects caused by this drug are nausea, vomiting, diarrhea, infection, decreased appetite, and fatigue.

October

INMAZEB

INMAZEB is the mixture of 3 monoclonal antibodies named ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB, used for treating Ebola virus infection among adults and kids. The drug is available as a solution for injection. The strength is 16.7MG/1ML. The most common side effects that could be seen while receiving Inmazeb are high temperature, chills, fast heart rate), fast breathing, and vomiting. Patients who receive Inmazeb should avoid the concurrent administration of a live vaccine.

Remdesivir

The U.S. Food and Drug Administration approved the antiviral drug remdesivir under the brand name Veklury for use in adults and kids aged above 12 years of age with at least 40 kilograms for treating COVID-19 infections requiring hospitalization. The drug should be given only in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. This is the first treatment for COVID-19 to receive FDA approval.

December

Ansuvimab

The USFDA approved Ansuvimab under the trade name "EBANGA" to treat children and adults who have ebolavirus infection. Dosage: The drug is available as an injection. It is given one time by a healthcare provider directly into the vein over one hour. The amount of the drug to be administered depends on the patient’s weight. Side effects: Fever, fast heart rate, diarrhea, vomiting, low blood pressure, and chills, etc.

Margetuximab

Margetuximab is approved under the trade name "MARGENZA" for the treatment of metastatic HER2-positive breast cancer in adults who were previously treated for their metastatic disease. Dosage: MARGENZA is available as an injection. It is given by a healthcare provider directly into the vein every three weeks along with chemotherapy. Side effects: Fatigue, nausea, diarrhea, and vomiting.

Relugolix

Relugolix was approved under the brand name "ORGOVYX" for treating adults with advanced prostate cancer. Dosage: ORGOVYX is available as 120mg tablets. Three tablets (total of 360 mg) are taken on the first day of treatment followed by one tablet once daily. Side effects: Hot flushes increased blood sugar levels, increased blood fat (triglyceride) levels, muscle and joint pain, low red blood cell count (anemia), increased liver enzymes, tiredness, constipation, and diarrhea.

Tirbanibulin

The US FDA approved Tirbanibulin under the brand name "KLISYRI" to treat patients with actinic keratosis(skin disorder due to long-term exposure to the sun) on the face or scalp. Dosage: Tirbanibulin is available as an ointment. One package of ointment is applied on the affected area of the face or scalp 1 time a day for 5 days in a row. Side effects: Local skin reactions, application site pruritus, and application site pain.

Vibegron

Vibegron is approved under the trade name GEMTESA, that is used to treat the following symptoms due to overactive bladder: 1.A strong need to urinate with leaking or wetting accidents, 2. The need to urinate right away, and 3. The need to urinate often. Dosage: It is available as a 75 mg tablet, to be taken by mouth once a day. Side effects: Headache, urinary tract infection, common cold, diarrhea, nausea, and upper respiratory tract infection, etc.