Browse the FDA Approved Drugs by Year
Browse 2014 FDA Approved Drugs by Month
January
Dapagliflozin
The U.S. Food and Drug Administration today approved Farxiga (dapagliflozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Gel sealant
The U.S. Food and Drug Administration today approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to today’s approval, stitches were the only option for closing a leaking corneal incision after cataract surgery.
Tasimelteon
The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor 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. This is the first FDA approval of a treatment for the disorder.
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Trametinib
This week the U.S. Food and Drug Administration approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage).
February
Dexcoms G4 Platinum
The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years.
Droxidopa
The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH).
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Elosulfase alfa
The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome).
Ibrutinib
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
Metreleptin for Injection
On Feb. 24, 2014, the U.S. Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy
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March
Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein
The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B.
Apremilast
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
Miltefosine
The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Topiramate
Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17.
April
Albiglutide
The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Ceritinib
The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)
Naloxone Hydrochloride Injection
The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet
Oralair
The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.
Ragwitek
The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
Ramucirumab
The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.
Siltuximab
The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).
May
Celecoxib
The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.
Dalbavancin
The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
Entyvio (vedolizumab)
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.
Vorapaxar
The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
June
Afrezza (insulin human) Inhalation Powder
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal
Fc fusion protein
The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
Tedizolid Phosphate
The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.
Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use.
July
Belinostat
The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.
Idelalisib
The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.
Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed). Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities).Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL.
Olodaterol
Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time
Ruconest
The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets)
Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry,
August
Eliglustat
The U.S. Food and Drug Administration approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.
Cerdelga is a hard gelatin capsule containing eliglustat that is taken orally. In patients with Gaucher disease Type 1, the drug slows down the production of the fatty materials by inhibiting the metabolic process that forms them. Type 1 Gaucher disease is estimated to affect about 6,000 people in the United States.
Empagliflozin
The U.S. Food and Drug Administration approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose (blood sugar) by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. The drug’s safety and effectiveness were evaluated in seven clinical trials with 4,480 patients with type 2 diabetes receiving Jardiance. The pivotal trials showed that Jardiance improved hemoglobin A1c levels (a measure of blood sugar control) compared to placebo.
Oritavancin
The U.S. Food and Drug Administration approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously.
Suvorexant
The U.S. Food and Drug Administration approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.
September
Dulaglutide
The U.S. Food and Drug Administration approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type 2 diabetes received Trulicity. Patients receiving Trulicity had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).
Naloxegol
The U.S. Food and Drug Administration approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo (sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.
Pembrolizumab
The U.S. Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.
October
Ledipasvir and Sofosbuvir
The U.S. Food and Drug Administration approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Lumason(sulfur hexafluoride lipid microsphere)
The U.S. Food and Drug Administration approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.
Lumason is a contrast agent made up of gas-filled microbubbles (or microspheres) that reflect the sound waves to enhance the image. Lumason helps a physician see a patient's heart more clearly, allowing for clearer imaging of the left ventricle chamber and the smooth edge on the inside of the chambers of the heart, known as the endocardium.
Netupitant and Palonosetron
The U.S. Food and Drug Administration approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.
Nintedanib
The U.S. Food and Drug Administration approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,231 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Ofev compared to patients receiving placebo.
Pirfenidone
The U.S. Food and Drug Administration approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,247 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Esbriet compared to patients receiving placebo.
December
Blinatumomab
The U.S. Food and Drug Administration approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. Blincyto is the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. It is intended for patients whose cancer returned after treatment (relapsed) or did not respond to previous treatment (refractory).
Ceftolozane/ Tazobactam
The U.S. Food and Drug Administration approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole to treat cIAI.
Finafloxacin Otic Suspension
The U.S. Food and Drug Administration approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.
Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.
Nivolumab
The U.S. Food and Drug Administration granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.
Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.
Olaparib
The U.S. Food and Drug Administration granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
Peramivir
The U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults.
Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. Rapivab is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days.
Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets)
The U.S. Food and Drug Administration approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).
