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 these products 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 2012.

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

To treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
Press Release

A Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.
Press Release

For the treatment of adults with relapsing forms of multiple sclerosis (MS).
Press Release

To treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.
Press Release

To treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
Press Release

To treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. 
Press Release

To reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
Press Release

A once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
Press Release 

For use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer. 
Press Release 

For the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 
Press Release 

carfilzomib

7/20/12

sodium picosulfate, magnesium oxide and citric acid

7/17/12

To help cleanse the colon in adults preparing for colonoscopy.
Press Release

mirabegron

 6/28/12

To treat adults with overactive bladder.
Press Release

lorcaserin hydrochloride

 6/27/12

For chronic weight management.
Press Release

pertuzumab

 6/8/12

To treat patients with HER2-positive late-stage (metastatic) breast cancer.
Press Release

taliglucerase alfa

 5/1/12

For long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder
Press Release

avanafil

 4/27/12

To treat erectile dysfunction.
Press Release

Florbetapir F 18

 4/6/12

Used as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.

peginesatide

 3/27/12

lucinactant

 3/6/12

tafluprost

 2/10/12

ivacaftor

 1/31/12

For the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
Press Release

vismodegib

 1/30/12

To treat adult patients with basal cell carcinoma, the most common type of skin cancer.
Press Release

axitinib

 1/27/12

To treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
Press Release

ingenol mebutate

 1/23/12

For the topical treatment of actinic keratosis.

glucarpidase

 1/17/12

To treat patients with toxic levels of methotrexate in their blood due to kidney failure.
Press Release