Comprehensive list of FDA approved drugs by year. Drug information includes the drug name and indication of use.
January
FDA approves Kineret (anakinra) for the treatment of NOMID
U.S. FDA Approves Bayer's Skyla (Levonorgestrel-Releasing Intrauterine System) 13.5 mg For Prevention Of Pregnancy For Up To Three Years
Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
FDA Approves Flublok (influenza vaccine, recombinant hemagglutinin) - New Seasonal Influenza Vaccine Made Using Novel Technology
FDA Approves Octaplas (pooled plasma (human)) to Treat Patients with Blood Clotting Disorders
FDA Approves Botox (onabotulinumtoxinA) to Treat Overactive Bladder
NuPathe's Zecuity (sumatriptan) Approved by the FDA for the Acute Treatment of Migraine
FDA Approves Exjade (deferasirox) to Remove Excess Iron in Patients with Genetic Blood Disorder
Pfizer Receives FDA Approval For The Use Of Prevnar 13 (pneumococcal 13-valent conjugate vaccine)In Vaccine-Naive Children And Adolescents Aged 6 Years Through 17 Years For The Prevention Of Invasive Pneumococcal Disease
FDA Approves Gleevec (imatinib mesylate) for Children with Acute Lymphoblastic Leukemia
FDA Approves Over-the-Counter Oxytrol ((oxybutynin) Transdermal System ) for Women to treat Overactive Bladder
Takeda Receives FDA Approval for Nesina (alogliptin) for Type 2 Diabetes
Takeda Receives FDA Approval for Oseni (alogliptin and pioglitazone) for Type 2 Diabetes
Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes
FDA Approves New Orphan Drug Kynamro (mipomersen) to Treat Inherited Cholesterol Disorder
February
FDA approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection)
FDA approves Stivarga (regorafenib) for advanced gastrointestinal stromal tumors
FDA approves Osphena (ospemifene) for postmenopausal women experiencing pain during sex
FDA approves Kadcyla (ado-trastuzumab emtansine), new treatment for late-stage breast cancer
FDA approves Pomalyst (pomalidomide) for advanced multiple myeloma
FDA approves new drug Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders
FDA approves Stivarga (regorafenib) for advanced gastrointestinal stromal tumors
March
FDA approves new multiple sclerosis treatment: Tecfidera (dimethyl fumarate)
FDA approves TOBI Podhaler (tobramycin inhalation powder) to treat a type of bacterial lung infection in cystic fibrosis patients
FDA approves Lymphoseek (technetium Tc 99m tilmanocept) to help locate lymph nodes in patients with certain cancers
FDA approves Invokana (canagliflozin) to treat type 2 diabetes
Equine
FDA approves first Botulism Antitoxin (Equine) for use in neutralizing all seven known botulinum nerve toxin serotypes
FDA approves Dotarem (gadoterate meglumine), a new magnetic resonance imaging agent
April
FDA approves Procysbi (cysteamine bitartrate) for rare genetic condition
FDA approves abuse-deterrent labeling for reformulated OxyContin (oxycodone hydrochloride controlled-release)
FDA approves Plan B One-Step (levonorgestrel) emergency contraceptive without a prescription for women 15 years of age and older
Prothrombin Complex Concentrate, Human
FDA approves Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of anticoagulation in adults with major bleeding
FDA approves Diclegis (doxylamine succinate and pyridoxine hydrochloride) for pregnant women experiencing nausea and vomiting
May
FDA approves Nymalize-first nimodipine oral solution for use in certain brain hemorrhage patients
Fluticasone Furoate and Vilanterol Inhalation Powder
FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease
FDA approves Tafinlar (dabrafenib), companion diagnostic test for advanced skin cancer
FDA approves Mekinist (trametinib), companion diagnostic test for advanced skin cancer
FDA approves Simponi (golimumab) to treat ulcerative colitis
FDA approves new drug Xofigo (radium Ra 223 dichloride) for advanced prostate cancer
FDA approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib)
June
FDA approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause
Coagulation Factor IX (Recombinant)
FDA approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older
FDA approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential
FDA approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor
FDA approved the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus
July
FDA approves Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC)
August
The U.S. Food and Drug Administration approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
September
The U.S. Food and Drug Administration today Brintellix (vortioxetine) to treat adults with major depressive disorder.
The U.S. Food and Drug Administration expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
The U.S. Food and Drug Administration approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
The U.S. Food and Drug Administration granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting)
October
Hydrocodone Bitartrate ER capsules
The U.S. Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
Vizamyl (flutemetamol F 18 injection)
The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.
Opsumit (macitentan)
The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
Adempas (riociguat)
The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
Clinolipid
The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink. Clinolipid was granted a priority review to help alleviate a drug shortage.
November
Olysio (simeprevir)
The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.
Influenza A (H5N1) Virus Monovalent Vaccine
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.
The U.S. Food and Drug Administration today expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer
The U.S. Food and Drug Administration today approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
Eslicarbazepine Acetate
The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Rabeprazole Sodium Delayed-Release Tablets
The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
December
Tretten ( Coagulation Factor XIII A-Subunit (Recombinant)
The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.
Umeclidinium and Vilanterol Inhalation Powder
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Duloxetine Delayed Release Capsules
The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
Xiaflex (collagenase clostridium histolyticum)
The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
Careers
