New Molecular Entity Approvals for 2011
In calendar year 2011, CDER approved a wide range of new brand name and generic drug products. Many are duplicate therapies that will compete in the marketplace with the same kind of products already approved. But some are new and innovative chemical structures never used before in clinical practice. Such novel new drugs are often called new molecular entities (NMEs). Many of these products offer new hope for patients suffering from the conditions these products are intended to treat. The list below includes the NMEs approved by CDER in calendar year 2011.
FDA's Center for Biologics Evaluation and Research (CBER) approves biological drugs. At the end of Fiscal Year 2011, FDA examined the combined drug approvals of both CDER and CBER for FY 2011 (see report).
Below summarizes the NMEs approved by CDER in calendar year 2011:
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CDER User Fee Performance &
Drug Approvals - 2011
What it’s used for
To treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.
asparaginase Erwinia chrysanthemi
To treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
To treat patients with the bone marrow disease myelofibrosis.
For use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.
To treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
To treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
For the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.
For the treatment of Hodgkin lymphoma and ALCL (systemic anaplastic large cell lymphoma). Press Release
To treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).
To reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.
indacaterol inhalation powder
For the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
To prevent acute rejection in adult patients who have had a kidney transplant.
For use as an add-on medication to treat seizures associated with epilepsy in adults.
For the treatment of Clostridium difficile-associated diarrhea (CDAD).
For the treatment of HIV-1 infection in adults who have never taken HIV therapy.
An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
In combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
To treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.
A once-daily treatment for moderate-to-severe restless legs syndrome (RLS).
To treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
For use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system.
To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).
To treat high blood pressure (hypertension) in adults.
To treat major depressive disorder in adults.
For the treatment of head lice infestation in patients ages 4 years and older.
An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).