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U.S. Department of Health and Human Services

Drugs

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New Molecular Entity Approvals for 2013

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.

Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. 

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of theseproducts contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.

 

The list below includes the NMEs approved by CDER in calendar year 2013.

(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)

2012 Novel New Drugs Summary
2012 Novel New Drugs Summary


No.

Drug Name

Active Ingredient

Date

What it’s used for

27.Anoro Elliptaumeclidinium and vilanterol inhalation powder12/18/2013 For the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Press Release
26.Sovaldisofosbuvir12/6/2013To treat chronic hepatitis C virus (HCV) infection.
Press Release
25.Olysiosimeprevir11/22/2013To treat chronic hepatitis C virus infection.
Press Release
24.Luzululiconozole11/14/2013For the 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.
23.Imbruvicaibrutinib11/13/2013To treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
Press Release
22.Aptiomeslicarbazepine acetate11/8/2013As an add-on medication to treat seizures associated with epilepsy.
Press Release
21.Gazyvaobinutuzumab11/1/2013For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
Press Release
20.Vizamylflutemetamol F 18 injection10/25/13A 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.
Press Release
19.Opsumitmacitentan10/18/13To treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
Press Release
18.Adempasriociguat10/8/13To treat adults with two forms of pulmonary hypertension.
Press Release
17.Duaveeconjugated estrogens/bazedoxifene10/3/13To treat moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.
Web Posting
16.Brintellixvortioxetine9/30/13To treat adults with major depressive disorder.
Press Release
15.Tivicaydolutegravir8/12/13To treat HIV-1 infection.
Press Release
*    
14.Gilotrifafatinib7/12/13For 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.
Press Release
13.Mekinisttrametinib5/29/13To treat patients whose tumors express the BRAF V600E or V600K gene mutations.
Press Release
12.Tafinlardabrafenib5/29/13To treat patients with melanoma whose tumors express the BRAF V600E gene mutation.
Press Release
11.Xofigoradium Ra 223 dichloride5/15/13To treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.
Press Release
10.Breo Elliptafluticasone furoate and vilanterol inhalation powder5/10/13For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Press Release
9.Invokanacanagliflozin3/29/13Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Press Release
8.Tecfideradimethyl fumarate3/27/13To treat adults with relapsing forms of multiple sclerosis (MS).
Press Release
7.Dotaremgadoterate meglumine3/20/13For use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Press Release
6.Lymphoseektechnetium Tc 99m tilmanocept3/13/13A 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.
Press Release
5.Osphenaospemifene2/26/13To treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Press Release
4.Kadcylaado-trastuzumab emtansine2/22/13For patients with HER2-positive, late-stage (metastatic) breast cancer.
Press Release
3.Pomalystpomalidomide2/8/13To treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
Press Release
2.Kynamromipomersen sodium1/29/13To treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).
Press Release
1.Nesinaalogliptin1/25/13To improve blood sugar control in adults with type 2 diabetes.
Press Release

* Correction: Simponi Aria, posted on 7/18/2013 was removed from this list on 9/17/2013. The product was inadvertently posted on this site.