Novel Drug Approvals for 2012

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.)


Drug Name

Active Ingredient


What it’s used for

To treat HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite.
Press Release
As part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
Press Release
To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Press Release
To reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH).
Press Release
To treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).
Press Release
To treat Cushing’s disease patients who cannot be helped through surgery
Press Release
 33.raxibacumabraxibacumab12/14/12To treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis.
Press Release

To treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.
Press Release


To treat medullary thyroid cancer that has spread to other parts of the body (metastasized).
Press Release


To treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.
Press Release

 29.Synriboomacetaxine mepesuccinate10/26/12 

To treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
Press Release


To treat partial onset seizures in patients with epilepsy ages 12 years and older.
Press Release


To treat an eye condition called symptomatic vitreomacular adhesion (VMA).
Press Release


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

 25.Choline C 11 InjectionCholine C 11 Injection9/12/12 

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

 19.Stribildelvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate8/27/12 

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 

 17.Tudorza Pressairaclidinium bromide7/23/12 

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




To treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory.
Press Release

sodium picosulfate, magnesium oxide and citric acid


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




To treat adults with overactive bladder.
Press Release


lorcaserin hydrochloride


For chronic weight management.
Press Release




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


taliglucerase alfa


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




To treat erectile dysfunction.
Press Release


Florbetapir F 18


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.




To treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
Press Release



For the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.
Press Release



For reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Press Release



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




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




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


For the topical treatment of actinic keratosis.




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


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