FDA Approved Drugs in 2019

February

Antihemophiliac factor

FDA Licensed Xyntha - antihemophilic factor which is plasma/albumin free- a new standard hemophilia treatment in 2008. Esperoct is the trade name for glycopegylated-antihemophilic factor approved by the FDA in February 2019. It has an extended half-life. It provides 1.6-fold half-life prolongation in adults and adolescents and 1.9-fold half-life prolongation in children, compared to standard half-life factor VIII products.

Caplacizumab-yhdp

The Food and Drug Administration approved caplacizumab-yhdp for adults with acquired thrombotic thrombocytopenic purpura (aTTP)- a bleeding disorder due to defective platelets, to be used in combination with plasma exchange and immunosuppressants. The effect of caplacizumab-yhdp was established based upon time-to-platelet count response. Dosage: Initial dose of caplacizumab-yhdp is 11 mg intravenous(into the vein) injection 15 minutes before plasma exchange followed by 11 mg subcutaneous(into the fat) injection after plasma exchange completion.It has to be continued daily for 30 days after the last plasma exchange. The common adverse reactions reported among patients receiving caplacizumab-yhdp were epistaxis(nose bleeding), headache, and gingival(gum) bleeding.

Esketamine

The U.S. Food and Drug Administration approved Esketamine nasal spray under the trade name Spravato to be used along with an oral antidepressant for treating depression in adults who have tried other antidepressants but have not benefited from them (treatment-resistant depression). Due to the risk of serious adverse effects, it is available only through a limited distribution system under Risk Evaluation and Mitigation Strategy (REMS).

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Herceptin Hylecta

Herceptin Hylecta is an FDA approved, fixed-dose combination of trastuzumab with recombinant human hyaluronidase enzyme. It is used for treating adults with HER2 overexpressing node positive or node negative ER/PR negative breast cancer. The recommended dose of Herceptin Hylecta is 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously over 2-5 minutes once every three weeks.

PrabotulinumtoxinA-xvfs

PrabotulinumtoxinA-xvfs is an acetylcholine(neurotransmitter) release inhibitor and a neuromuscular blocker approved for improving the appearance of glabellar lines (vertical lines that appear between the eyebrows) associated with corrugator and/or procerus muscle( muscles acting on eyebrow) activity in adults temporarily. Dosage: 0.1 mL (4 Units) by intramuscular(into the muscle) injection into five sites with a total dose of 20 Units. The most common adverse reactions are Headache, Eyelid Ptosis(drooping), Upper Respiratory Tract Infection, Increased White Blood Cell count etc. PrabotulinumtoxinA-xvfs should not be used in patients with Hypersensitivity(allergy) to botulinum toxin or any components in the formulation.

Sumatriptan

Sumavel DosePro is the trade name of sumatriptan injection approved by FDA for Acute Migraine and Cluster Headache in 2009 July. Sumatriptan Nasal spray was approved in 2019 February for the acute treatment of migraine with or without aura in adults.

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Triclabendazole

Triclabendazole, an antihelminthic drug is available as 250 mg tablet for treating fascioliasis(liver fluke infection) in patients aged above six years. It should be taken by mouth in two divided doses 12 hours apart. It may prolong the QT interval. So, regular monitor of ECG in patients with a history of QT prolongation is required. Side effects caused by triclabendazole includes abdominal pain, hyperhidrosis(increased sweating), nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus(itching). Triclabendazole is used for treating fascioliasis in humans since 1986. In 1997, after the success of clinical trials for treating fascioliasis and paragonimiasis, the WHO recommended that the drug should be placed on the Essential Drugs List. But the U.S. Food and Drug Administration (FDA) has not approved it's use in humans at that time, although it is registered in some countries where fascioliasis is endemic. Now it was approved by the US FDA (February 2019) to treat human fascioliasis.

March

Brexanolone

The U.S. FDA approved Brexanolone for treating postpartum depression in adult women. It is administered as a continuous IV infusion over 2.5 days. It can sudden loss of consciousness. so, patients must be monitored for excessive sedation and have continuous pulse oximetry monitoring. The most common side effects seen in clinical trials are sleepiness, dry mouth, loss of consciousness and flushing. Brexanolone will be available only through the Risk Evaluation and Mitigation Strategy (REMS).

Netarsudil and Latanoprost combination

The US FDA approved a fixed-dose combination containing latanoprost- 0.05 mg/mL, a prostaglandin analog and Netarsudil-0.2 mg/mL, a Rho kinase (ROCK) inhibitor under the trade name Rocklatan. Rocklatan is used for reducing the elevated intraocular pressure (IOP) among patients with open-angle glaucoma. It is available as a solution for topical ophthalmic(into the eye) administration. The recommended dosage is one drop in the affected eye once daily. Side effects associated with this combination are Conjunctival hyperemia (redness), conjunctival hemorrhage and Instillation site pain

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Siponimod

The U.S. Food and Drug Administration approved siponimod tablets to treat adults with certain types of multiple sclerosis like relapsing form, relapsing-remitting form, and secondary progressive disease. It may increase the risk of infections. So, patients should check complete blood count before starting treatment with sipoinimod. Women in childbearing age should use proper contraception for 10 days after stopping this drug due to risk of harm to developing baby. The most common side effects reported by patients receiving siponimod are headache, high blood pressure.

Soriamfetol

FDA approved Soriamfetol to improve wakefulness or alertness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea(OSA). It is not indicated to treat airway obstruction in OSA. It is available as 75 mg and 150 mg tablet. Avoid intake of soriamfetol 9 hours before bedtime because as it could interfere with sleep. Blood Pressure and Heart Rate should be monitored throughout the treatment Avoid use of soriamfetol in patients with serious heart diseases. Caution is required for treating patients with a history of psychosis or bipolar disorders.

April

Erdafitinib

The U.S. Food and Drug Administration approved Erdafitinib to treat adults with locally advanced or metastatic bladder cancer with genetic alterations in FGFR3 or FGFR2, which has progressed during or after platinum-containing chemotherapy. Common side effects reported were increased phosphate level, mouth sores, tiredness, diarrhea, dry mouth, etc. Doctors should inform male patients with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose. Pregnancy testing is recommended for females in reproductive age before initiating treatment with Erdafitinib.

RISANKIZUMAB-RZAA

Risankizumab-rzaa is approved by the FDA for treating moderate-to-severe plaque psoriasis in patients who are suitable for systemic therapy or phototherapy. It is given 150 mg injection (two 75 mg injections) administered by subcutaneous route during Week 0, Week 4 and every 12 weeks. It may increase the chance of infection. Patients are instructed to take medical advice if signs or symptoms of infection occur. Common side effects reported are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

Romosozumab-aqqg

The U.S. Food and Drug Administration approved romosozumab-aqqg for treating osteoporosis in postmenopausal women who are at high risk of fracture. Romosozumab is a monoclonal antibody that blocks the effects of the protein sclerostin. It acts mainly by increasing new bone formation. Two injections, one immediately following the other, given monthly once helps to relieve symptoms of osteoporosis. More than 12 doses should not be used as bone forming effect decreases after 12 doses. Common side effects reported with romosozumab were joint pain, headache and injection site reactions

May

Alpelisib

The Food and Drug Administration approved Alpelisib tablets to be used in combination with fulvestrant for treating postmenopausal women, and men, with a specific type of breast cancer. Common side effects reported are high blood sugar levels, diarrhea, rash, elevated liver enzymes, nausea, fatigue, low red blood cell count, increase in lipase, decreased appetite, etc. Doctors are advised to monitor patients taking for severe allergic reactions during Alpelisib treatment.

Tafamidis meglumine

The U.S. Food and Drug Administration approved Tafamidis meglumine under the trade name Vyndaqel and Tafamidis with trade name Vynamax for treating a type of heart disease called cardiomyopathy in adults caused by transthyretin-mediated amyloidosis. They are available as capsules to be used orally. The recommended dosage is either: • Tafamidis meglumine 80 mg orally once daily, or • Tafamidis 61 mg orally once daily They can interact with breast cancer resistant protein substrates.

June

Polatuzumab

The U.S. Food and Drug Administration approved Polatuzumab vedotin-piiq (trade name- Polivy) to be used in combination with Bendamustine and Rituximab (BR) to treat diffuse large B-cell lymphoma (DLBCL) that has progressed or relapsed after treatment among adults. It is an antibody that is attached to the chemotherapy drug. The most common side effects caused by polatuzumab and BR combination are low white blood cell count, low platelets and red blood cells, nerve damage, tiredness, diarrhea, fever, decreased appetite, and pneumonia.

July

Bremelanotide

The U.S. Food and Drug Administration approved Bremelanotide to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It acts by activating melanocortin receptors, but the mechanism by which it increases sexual desire is unknown. Patients should inject the drug under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity. The most common side effects reported are nausea & vomiting, flushing, injection site reactions, and headache.

Darolutamide

Darolutamide is approved by the FDA under the brand name- Nubeqa It is prescribed to treat non-metastatic(not spread to other parts) prostate cancer which doesn't respond to the medical or surgical treatment that decreases testosterone. The dose is 300mg two tablets(total dose- 600mg) to be taken with food Adequate care should be taken while prescribing Darolutamide to patients with 1.kidney or liver problems 2.pregnant or planning to become pregnant. Common side effects seen with Darolutamide include feeling more tired than usual, arm, leg, hand or foot pain, rash etc

Ferric Maltol

Ferric maltol capsules are used for treating iron deficiency in adults. It was approved by the FDA under the brand name ACCRUFER. It should be taken as 30 mg capsule two times a day on an empty stomach. Patients having an allergy to iron and who are receiving repeated blood transfusions should not use ferric maltol. Common side effects seen are flatulence, diarrhea, constipation, black stool, abdominal pain, nausea, vomiting, etc. Ferric maltol should not be given along with Dimercaprol

Imipenem, Cilastatin and Relebactam combination

The U.S. Food and Drug Administration approved Recarbrio containing imipenem, cilastatin and relebactam, to treat adults suffering from complicated urinary tract infections and complicated intra-abdominal infections. The three drug injection contains imipenem-cilastatin, which was previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor. The most common adverse reactions seen in patients treated with Recarbrio are nausea, diarrhea, headache, fever and raised liver enzymes. It should be avoided in patients using ganciclovir, valproic acid unless benefits outweigh risks.

SELINEXOR

Selinexor was approved by the United States Food and Drug Administration (FDA) to be used in combination with dexamethasone for treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have taken at least four previous therapies. It is given in the form of tablet orally- 80mg on days 1 and 3 each week Common side effects reported are low platelet count, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting etc.

August

Fedratinib

The Food and Drug Administration approved Fedratinib under the trade name Inrebic to treat adults with few types of myelofibrosis. Myelofibrosis is a chronic disorder in which scar tissue forms in the bone marrow. Common side effects are diarrhea, nausea, vomiting, fatigue and muscle spasms. Iron levels and platelet count should be monitored regularly in patients who are taking Fedratinib.

Ga 68 DOTATOC

Ga 68 DOTATOC injection is a diagnostic agent used with a scan named positron emission tomography (PET) for localization of tumors called somatostatin receptor-positive neuroendocrine tumors (NETs). It can be used for both adults and kids. The recommended dose for adults is 148 MBq (4 mCi) to be given as a bolus intravenous injection. Common side effects seen are Nausea, pruritis, and flushing.

Istradefylline

The U.S. Food and Drug Administration approved istradefylline tablets under the trade name Nourianz as an add-on therapy to levodopa/carbidopa in adults with Parkinson’s disease experiencing "off" episodes. The most common side effects seen in patients taking istradefylline tablets are involuntary muscle movements, dizziness, constipation, nausea, hallucination, and sleeplessness (insomnia).

LEFAMULIN ACETATE

The U.S. Food and Drug Administration approved lefamulin under the trade name Xenleta to treat adults with an infectious disease called community-acquired bacterial pneumonia(CABP). The safety and efficacy of the drug taken was evaluated in two clinical trials with a total of 1,289 patients with CABP. Dosage: 600mg oral tablets to be taken orally It can also be used by intravenous route. The most common side effects reported are diarrhea, nausea, reactions at the injection site etc

Pexidartinib

The U.S. Food and Drug Administration granted approval to Pexidartinib with brand name Turalio for treating adult patients with symptomatic treatment-resistant tenosynovial giant cell tumor (TGCT) associated with functional limitations. Dosage is 200mg oral capsules. Health care providers must monitor liver function tests before beginning treatment with Pexidartinib and at specified intervals. Common side effects seen were increased lactate dehydrogenase (which helps produce energy in the body), increased aspartate aminotransferase (an enzyme that is present in the liver and muscles), loss of hair color, enhanced alanine aminotransferase (the enzyme that is seen in the liver and kidney) and increased cholesterol.

Pitolisant

Pitolisant is approved by the FDA to treat excessive daytime sleepiness (EDS) in adults with narcolepsy under the brand name Wakix. It is a histamine receptor antagonist/inverse agonist- inhibiting the effects of a chemical mediator named histamine in the body. Dosage: Initial dose is 9 mg (two 4.5 mg, tablets) per day. It should be used at the lowest possible effective dose. The dose should not exceed 36 mg/day.

Pretomanid

The FDA approved Pretomanid Tablets to be used in combination with bedaquiline and linezolid for treating treatment-resistant tuberculosis(TB). It is approved only for patients with extensively drug-resistant, treatment-intolerant or nonresponsive multidrug-resistant pulmonary TB. The most common side effects observed in patients treated with Pretomanid in combination with bedaquiline and linezolid are nerve damage (peripheral neuropathy), pimples (acne), anemia, nausea, vomiting, headache, etc. The combination should not be used in patients with allergy to bedaquiline or linezolid.

Upadacitinib

UPADACITINIB HEMIHYDRATE 15mg tablet once daily is indicated for treating adults with moderate to severely rheumatoid arthritis that showed an inadequate response or intolerance to methotrexate. Caution is required while using this tablet in patients with active, serious Infections and who are at risk of gastrointestinal perforation. Pregnant, breast feeding women should not use upadacitinib Common side effects seen are upper respiratory tract infections, nausea, cough, and pyrexia. Live vaccination is not recommended while using upadacitinib tablets

September

Tenapanor

US FDA approved Tenapanor under the brand name ÍBSRELA to treat constipation in irritable bowel syndrome adults. It should not be used in patients below 12 years of age. Dosage: 50 mg tablets should be taken by mouth two times a day- just before breakfast and one tablet immediately before dinner. Most common side effects observed are diarrhea, abdominal pain, and dizziness Inform your doctor if you are pregnant or breastfeeding.

October

Afamelanotide

The U.S. Food and Drug Administration approved Afamelanotide to increase pain-free light exposure in adults with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. It's most common side effects are implanted site reaction, nausea, pain, cough etc It should be administered by a specialized health care professional in the subcutaneous tissue(below the skin). The drug approved under the brand name 'Scenesse' also received Orphan Drug status, which provides grants to assist and encourage the development of drugs for rare diseases.

Brolucizumab

Brolucizumab was approved under the brand name 'BEOVU' for treating neovascular (wet) Age-Related Macular Degeneration (AMD), which is a disease of the retina - a layer of the eye that contains cells which are sensitive to light. The drug comes as an injection, injected by a healthcare professional directly inside the eyeball every month for three months and then every 8-12 weeks. The drug may few serious side effects like eyeball infection and inflammation(redness and swelling with pain)

Trifarotene

Trifarotene was approved under the brand name 'AKLIEF'. Dosage form: It comes as a cream to be applied for acne(pimples) in patients aged above 9 years once a day, in the evening, on clean and dry skin It is Not intended for oral, ophthalmic or intravaginal use. Avoid contact with the eyes, lips, paranasal lines. Common side effects (incidence ≥ 1%)seen in patients treated with Trifarotene cream were irritation and itching at the site of application.

Trikafta

The Food and Drug Administration approved elexacaftor/ivacaftor/tezacaftor under the trade name 'Trikafta, to treat patients with the most common cystic fibrosis mutation for patients aged above 12 years with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Side effects that occurred more commonly in patients receiving Trikafta compared to placebo were rash and flu. Liver function tests (transaminases and bilirubin) should be monitored regularly among the drug users

November

Air polymer-type A

FDA approved a diagnostic agent used to estimate fallopian tube function in women with known or suspected infertility called Air polymer-type A test. The patient should not be pregnant or having infections of the lower genital tract The dose used should be 2-3ml given into the uterus through a catheter

Air polymer-type A

FDA approved a diagnostic agent used to estimate fallopian tube function in women with known or suspected infertility called Air polymer-type A test. The patient should not be pregnant or having infections of the lower genital tract The dose used should be 2-3ml given into the uterus through a catheter

Cefiderocol

The U.S. Food and Drug Administration approved cefiderocol under the trade name Fetroja. It is an antibacterial drug used for the treatment of patients aged above 18 years with complicated urinary tract infections and kidney infections caused by Gram-negative microorganisms, who have limited or no alternative treatment options. The safety and effectiveness of the drug were demonstrated in a study on 448 patients. The most common side effects seen in patients treated were diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion site reactions, candidiasis etc.

Cenobamate

The U.S. Food and Drug Administration approved cenobamate under the brand name XCOPRI to treat adults with partial-onset seizures. It is available as a tablet to be taken orally (by mouth). Dose of tablets: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. It should not be used in patients with known allergy to cenobamate or any of the inactive ingredients in the dosage form and in patients with Familial Short QT syndrome( a kind of abnormal heart rhythm). The most common adverse effects that patients in the clinical trials reported were sleepiness, dizziness, fatigue, diplopia (double vision), and headaches.

Crizanlizumab-tmca

The U.S. Food and Drug Administration approved crizanlizumab-tmca under the trade name Adakveo. The drug is used to decrease the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells for patients aged above 16 years. Common side effects seen in patients taking the drug were back pain, nausea, pyrexia (fever) and arthralgia (joint pain), etc.

Givosiran

The U.S. Food and Drug Administration gave approval to Givosiran under the brand name 'Givlaari' for the treatment of adults with acute hepatic porphyria. It is a genetic disorder occurring due to accumulation of toxic porphyrin molecules. The approval was based on the results of a clinical trial on 94 patients with acute hepatic porphyria. Drug's performance was measured by the rate of porphyria attacks that required hospitalizations, urgent health care visits or intravenous infusion of hemin at home. Patients who received the drug experienced 70% less porphyria attacks compared to patients receiving a placebo. Common adverse effects seen among patients were nausea and injection site reactions. Allergic reactions, kidney and liver functions should be monitored.

Luspatercept–aamt

The U.S. Food and Drug Administration gave approval to luspatercept–aamt under the trade name Reblozyl for treating anemia in adult patients with beta thalassemia who need regular red blood cell transfusions. The approval was based on the results of a clinical trial of 336 patients with beta-thalassemia who required RBC transfusions. Common side effects caused by Reblozyl were headache, bone pain, joint pain, fatigue, cough, abdominal pain, diarrhea and dizziness.

Voxelotor

The U.S. Food and Drug Administration provided accelerated approval to voxelotor under the trade name Oxbryta for treating sickle cell disease (SCD) adults and pediatric patients aged above 12 years. SCD is a lifelong, inherited blood disorder in which red blood cells are abnormally shaped. It is available as 500mg oral tablets. The dose is 1500mg orally(by mouth) once daily for SCD. Common side effects observed with voxelotor are a headache, diarrhea, abdominal pain, nausea, fatigue, rash, and pyrexia(rise in body temperature).

Zanubrutinib

The U.S. Food and Drug Administration granted approval to zanubrutinib under the trade name Brukinsa. These capsules are used for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. Common side effects seen among patients taking Brukinsa were redcued neutrophil count , reduced platelet count, etc.

December

BRILLIANT BLUE G

The FDA approved brilliant blue G under the trade name TISSUEBLUE for staining the internal limiting membrane (ILM), which is a transparent membrane inside the eye that may cause impaired vision. It is injected into the eyeball by a healthcare professional during a surgical procedure. Brilliant blue stains ILM, which allows the transparent ILM to be seen and removed. It is available as a 0.025% ophthalmic solution. Side effects reported were retinal tears, bleeding and detachment, and cataracts.

Enfortumab

The U.S. Food and Drug Administration gave approval to Enfortumab vedotin-ejfv under the trade name Padcev, the drug that specifically targets cancer cells for treating urothelial locally advanced or metastatic cancers in adults. Common side effects caused by Enfortumab are fatigue or tiredness, nerve damage, decreased appetite, rash, alopecia (hair loss), nausea, etc. Patients should use effective contraception while taking treatment with Enfortumab. Women who are pregnant or breastfeeding should not take Enfortumab, as it may harm a developing fetus. It should be used as an intravenous infusion only. The dose to be given is 1.25 mg/kg as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

Fam-trastuzumab

The US FDA approved fam-trastuzumab deruxtecan-nxki under the trade name ENHERTU for treating adults with unresectable or metastatic HER2-positive breast cancer with metastasis. It should be given by intravenous infusion only. The patient should be monitored for complete blood counts prior to initiation of fam-trastuzumab and prior to each dose, and as clinically indicated. Patients left ventricle function should be assessed prior to initiation of fam-trastuzumab and at regular intervals during treatment as clinically indicated. Common side effects reported in clinical trials were nausea, fatigue, vomiting, alopecia, constipation, etc.

Golodirsen

The U.S. Food and Drug Administration approved Golodirsen under the brand name Vyondys 53 to treat Duchenne muscular dystrophy (DMD) patients with a confirmed mutation of the dystrophin gene, which is seen in around 8 percent of patients with DMD. Common adverse effects seen among participants receiving the drug were headache, fever (pyrexia), cough, vomiting, abdominal pain, cold symptoms (nasopharyngitis) and nausea.

LEMBOREXANT

The US FDA approved Lemborexant tablets for treating adult patients with insomnia(difficulties with sleep onset and/or sleep maintenance). The recommended dose is 5 mg once per night before going to bed The dose can be increased to 10 mg. Patients with liver failure or liver issues should discuss with their health care provider before taking the drug. It Impairs alertness and motor coordination. Hence driving is not recommended while using the drug. Common side effect seen was somnolence.

Lumateperone

Lumateperone is an atypical antipsychotic approved for the treatment of schizophrenia in adults. It is available as a capsule, to be taken once daily with food in the dose of 42mg. It should not be used in patients with a known allergy to Lumateperone or any of its components. It can cause cerebrovascular Adverse Reactions in older patients with dementia(memory problems) Common side effects reported in clinical trials were somnolence/sedation(increased sleepiness) and dry mouth. It should not be given in pregnant, breastfeeding women and patients with liver disorders

Ubrogepant

Ubrogepant, approved under the trade name UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. It should not be used for preventing the migraine. The recommended dose is 50 mg or 100 mg taken to be taken by mouth whenever required. The maximum dose to be used in a 24-hour period is 200 mg. The dose should be reduced if a patient suffers from renal or liver issues. Common side effects reported in clinical trials were nausea and somnolence(sleepiness).