New Drugs Approved in 2013
As of mid-December 2013, 27 new drugs, including 23 "New Molecular Entities", 2 new "Biologicals"(Gazyva and Kadcyla) and 1 new drug combination (Duavee), have been approved by the FDA for use in the U.S. This compares with 39 new drugs approved in 2012. Top categories of diseases for which new drugs were approved this year include cancer (9 drugs), diabetes (2 drugs), pulmonary hypertension (2 drugs), hepatitis C (2 drugs), and 3 new agents for use in diagnostic imaging. In addition, 4 of the drugs received "priority" review by the FDA: This is a special approval for a drug that appears to represent an advance over available therapy.
This chart provides a description of each new drug approved in 2013.
NEW DRUG APPROVALS in 2013 |
|||||||
DISEASE OR CONDITION |
DRUG NAME |
ACTIVE INGREDIENT |
APPROVAL DATE |
COMPANY |
FDA DESCRIPTION |
||
| Alzheimer's - diagnostic | Vizamyl | FLUTEMETAMOL F-18 | 10/25/2013 |
GE HEALTHCARE | 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. | ||
| Athlete's foot/Ringworm | Luzu | luliconazole | 11/14/2013 |
MEDICIS | Topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. | ||
| Cancer - Breast Cancer | Kadcyla |
ADO-TRASTUZUMAB EMTANSINE | 2/22/2013 |
GENENTECH | Treats patients with HER2-positive, late-stage (metastatic) breast cancer. | ||
| Cancer - Breast Cancer or Melanoma | Lymphoseek | TECHNETIUM TC-99M TILMANOCEPT | 3/13/2013 |
NAVIDEA BIOPHARMS | A radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. | ||
| Cancer - Lung | Gilotrif* | AFATINIB DIMALEATE | 7/12/2013 |
BOEHRINGER INGELHEIM | For patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. | ||
| Cancer - Lymphocatic Leukemia | Gazyva |
OBINUTUZUMAB | 11/1/2013 |
GENENTECH | For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). | ||
| Cancer - Mantle Cell Lymphoma | Imbruvica | ibrutinib | 11/13/2013 |
PHARMACYCLICS | Treatment for patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. | ||
| Cancer - Melanoma | Mekinist | TRAMETINIB DIMETHYL SULFOXIDE | 5/29/2013 |
GLAXOSMITHKLINE LLC | Treatment for patients whose tumors express the BRAF V600E or V600K gene mutations. | ||
| Cancer - Melanoma | Tafinlar | DABRAFENIB MESYLATE | 5/29/2013 |
GLAXOSMITHKLINE | Treatment for patients with melanoma whose tumors express the BRAF V600E gene mutation. | ||
| Cancer - multiple myeloma | Pomalyst |
POMALIDOMIDE | 2/8/2013 |
CELGENE | Treatment for patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. | ||
| Cancer - Prostate Cancer | Xofigo* | RADIUM RA-223 DICHLORIDE | 5/15/2013 |
BAYER HLTHCARE | Treatment for men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. | ||
| Depression | Brintellix Black Box warning suicidal thoughts and behavior risk |
VORTIOXETINE HYDROBROMIDE | 9/30/2013 |
TAKEDA PHARMS USA | For adults with major depressive disorder. | ||
| Diabetes | Nesina | ALOGLIPTIN BENZOATE | 1/25/2013 |
TAKEDA PHARMS USA | To improve blood sugar control in adults with type 2 diabetes. | ||
| Diabetes | Invokana | CANAGLIFLOZIN | 3/29/2013 |
JANSSEN PHARMS | Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. | ||
| Emphysema/COPD | Anoro Ellipta Black Box warning risk of asthma related death |
|
12/18/2013 | GLAXO GRP LTD | For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). | ||
| Emphysema/COPD | Breo Ellipta |
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | 5/10/2013 |
GLAXO GRP LTD | For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. | ||
| Epilepsy | Aptiom | ESLICARBAZEPINE ACETATE | 11/8/2013 |
SUNOVION PHARMS INC | As an add-on medication to treat seizures associated with epilepsy. | ||
| High Blood Pressure- Lungs (pulmonary hypertension) | Adempas* Black Box warning not for use in pregnant women because may cause fetal harm. |
RIOCIGUAT | 10/8/2013 |
BAYER HLTHCARE | Treatment for adults with two forms of pulmonary hypertension. | ||
| High Blood Pressure - Lungs (pulmonary hypertension) | Opsumit
|
MACITENTAN | 10/18/2013 |
ACTELION PHARMS LTD | Treatment for adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation. | ||
| High Cholesterol -inherited (rare) | Kynamro Black Box warning risk of hepatotoxicity |
MIPOMERSEN SODIUM | 1/29/2013 |
GENZYME CORP | Treatment for patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). | ||
| Menopause - Sexual Function | Osphena Black Box warning |
OSPEMIFENE | 2/26/2013 |
SHIONOGI INC | Treatment for women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause. | ||
| Menopause-hotflashes | Duavee Black Box warning - increased risk of endometrial cancer; risk of dementia and cardiovascular disorders |
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED | 10/3/2013 |
WYETH PHARMS PFIZER | Treatment for moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause. | ||
| MRI Diagnostic | Dotarem* Black Box warning not for use in those with kidney impairments as may causeNephrogenic systemic fibrosis (NSF) |
GADOTERATE MEGLUMINE | 3/20/2013 |
GUERBET | For use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older. | ||
| Multiple Sclerosis | Tecfidera | DIMETHYL FUMARATE | 3/27/2013 |
BIOGEN IDEC INC | For adults with relapsing forms of multiple sclerosis (MS). | ||
| Virus - Hepatitis | Sovaldi | SOFOSBUVIR | 12/6/2013 |
GILEAD SCIENCES INC | Treatment for chronic hepatitis C virus (HCV) infection. | ||
| Virus - HIV | Tivicay | DOLUTEGRAVIR SODIUM | 8/12/2013 |
VIIV HLTHCARE | Treatment for HIV-1 infection. | ||
| Virus -Hepatitis C | Olysio | SIMEPREVIR | 11/22/2013 |
JANSSEN RES AND DEV | For chronic hepatitis C virus infection. | ||
*priority review drug
Source: This chart compiled by AskaPatient with information from Drugs@FDA database and FDA drug approval report.