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FDA Approved Drugs in 2022


Comprehensive list of FDA approved drugs in the year 2022. Drug information includes the drug name and indication of use.

Browse the FDA Approved Drugs by Year

Browse 2022 FDA Approved Drugs by Month

January

Abrocitinib


Abrocitinib is indicated for treating adults with refractory, moderate-to-severe atopic dermatitis whose disease is not properly controlled with other medications. The recommended dosage is 100 mg orally once daily The drug is not recommended for use in combination with drugs affecting the immune system like biologic immunomodulators, or with other immunosuppressants. Common side effects include nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, urinary tract infection, tiredness, etc.

Daridorexant


Daridorexant is approved by the USFDA for treating adults with sleeplessness or insomnia. Dosage form: 25 mg and 50 mg tablets The recommended daily dose is 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed. The drug is contraindicated in patients with narcolepsy or excessive sleepiness Daridorexant may impair alertness and motor coordination including morning impairment. The most common aside effects were headache and somnolence or fatigue

Faricimab


Faricimab is approved for treating age-related macular degeneration and diabetic macular edema. Age-related macular edema is the swelling of the internal part of the eye that occurs due to degenerative changes occurring with age. The recommended dose is 6 mg given by intravitreal injection every 4 weeks for the first 4 doses. After that, dosage depends on eye assessments. The drug should not be used for patients having eye infections, eye swelling and redness(inflammation), and allergies.

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Tebentafusp


Tebentafusp is approved by the USFDA for treating adults with patients with unresectable or metastatic uveal melanoma. Uveal melanoma is cancer affecting the uvea-anterior part of the eye in which melanin cells multiply rapidly, The recommended dosage: 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week. Common side effects caused by the drug are cytokine release syndrome, fever, skin rash, itching, tiredness, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting

February

Mitapivat


Mitapivat is indicated for treating adults having anemia with an enzyme named is a pyruvate kinase deficiency. Dosage form: Tablets: 5 mg, 20 mg, and 50 mg. Starting dosage: 5 mg orally twice daily with or without food. Side effects reported in clinical trials were estrone decreased (males), increased urate, back pain, estradiol decreased (males), and bone pain. Patients with liver disorders should be cautious while using this medication.

Pacritinib


Pacritinib is approved for treating adults with myelofibrosis (a disorder of bone marrow) with a platelet count below 50 × 109/L (1). The drug is available as a capsule in a dose of 100mg. The recommended dosage is 200 mg orally twice daily. Common side effects caused by medication include diarrhea, low platelet count, nausea, anemia, and ankle swelling.

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Sutimlimab


Sutimlimab is approved by the USFDA to reduce the need for red blood cell transfusion due to hemolysis in cold agglutinin disease. Cold agglutinin disease is a form of anemia or low hemoglobin levels. The medication is available as an Injection: 1,100 mg/22 mL (50 mg/mL) in a single-dose vial Common side effects include respiratory tract infection, viral infection, diarrhea, dyspepsia, cough, arthralgia, arthritis, and ankle swelling.

March

Ganaxolone


Ganaxolone is approved under the trade name "ZTALMY" for treating seizures(fits) associated with an enzyme named cyclin-dependent kinase-like 5 (CDKL5) deficiency in patients aged 2 years and above. The medication is available as oral suspension Ganoxolone should be given orally three times daily with food. The dose should be increased slowly. The starting dosage is 18 mg/kg/day. The maximum dosage is 21 mg/kg three times daily. Most common side effects reported in clinical trials are excessive sleepiness, fever, salivary hypersecretion, and seasonal allergy.

Lutetium Lu 177


Lutetium Lu 177 is approved under the trade name "PLUVICTO". It is a radioligand therapeutic agent approved for treating prostate cancer. The drug should be given as 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses. (2.3) Dosage form: Injection: 1,000 MBq/mL (27 mCi/mL) in a single-dose vial. Most common side effects reported are tiredness or fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. Most common laboratory abnormalities reported in clinical trials are decreased lymphocytes(white blood cells), decreased hemoglobin, decreased platelets, decreased calcium, and decreased sodium.

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Nivolumab and Relatlimab


The combination of "Nivolumab and Relatlimab" is approved under the trade name "OPDUALAG". This combination is approved for the treatment of skin cancer named melanoma in patients aged 12 years and above. The dose is 480 mg nivolumab and 160 mg relatlimab to be injected into the vein every 4 weeks. The infusion should be given for 30 minutes. Common side effects reported are musculoskeletal pain, tiredness, itching, rash, pruritus, and diarrhea. The most common laboratory abnormalities are low hemoglobin, decreased lymphocytes(white blood cells), increased liver enzymes, and decreased sodium.

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