Recent FDA Approvals
What's new in pharmaceutical innovation? Here you can find the latest "New Molecular Entities" (NMEs) and biological products approved by the FDA this year. An NME is a new medicine that has a different molecular structure from any medicines approved before. NMEs and biologics represent just some of the significant pharmaceutical advances approved each year. New medicines this year treat diseases from the very common to the most rare. Some are the first treatment option available for a condition, others improve care for treatable diseases.
The descriptions here are primarily based on information from the FDA and NIH websites. Additional information about these products, including important safety information, can be obtained from the FDA-approved package insert.
BystolicTM – nebivolol hydrochloride – approved 12/17/2007
For the treatment of high blood pressure.
KuvanTM – sapropterin dihydrochloride – approved 12/13/2007
Indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobioterin (BH4) responsive PKU and is to be used in conjunction with a Phe-restricted diet.
Mircera® – methoxy polyethlene glycol-epoetin beta – approved 11/14/2007
For the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
Tasigna® – nilotinib – approved 10/29/2007
For the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia in adults resistant to or intolerant to prior therapy that included Gleevec.
Ixempra® – ixabepilone – approved 10/16/2007
For the treatment, in combination with capecitabine, of metastatic or locally advanced breast cancer resistant to other therapies; also used alone in treatment of metastatic or locally advanced breast cancer resistant to other therapies.
DoribaxTM – doripenem – approved 10/12/2007
For the treatment of complicated intra-abdominal and complicated urinary tract infections caused by susceptible bacteria.
IsentressTM – raltegravir potassium – approved 10/12/2007
For the treatment of HIV-1 infection in combination with other antiretroviral agents in treatment-experienced adults who have evidence or viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
Afluria® – influenza virus vaccine – approved 9/28/2007
For the active immunization of adults 18 and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
ACAM2000TM – smallpox vaccine – approved 9/10/2007
For the prevention of smallpox in people at high risk of exposure.
Somatuline depot® – lanreotide acetate – approved 8/30/2007
For the long-term treatment of patients with acromegaly who have had inadequate response to or can not be treated with surgery and/or radiation therapy.
EvithromTM – human thrombin – approved 8/28/2007
An aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical.
Ammonia N 13 – ammonia, N-13 – approved 8/23/2007
A radioactive diagnostic agent for Positron Emission Tomography (PET), for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
SelzentryTM – maraviroc – approved 8/6/2007
For use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood.
LetairisTM – ambrisentan – approved 6/15/2007
For the treatment of pulmonary arterial hypertension.
ToriselTM – temsirolimus – approved 5/30/2007
For the treatment of renal cell carcinoma.
Neupro® – rotigotine – approved 5/9/2007
For the treatment of symptoms of early Parkinson's disease.
Altabax® – retapamulin – approved 4/12/2007
Topical treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in patients aged 9 months or older.
Ceprotin – protein C concentrate (human) – approved 3/30/2007
For the treatment of Protein C deficiency.
Soliris®– eculizumab – approved 3/16/2007
For the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
Tykerb® – lapatinib – approved 3/13/2007
For the treatment of advanced metastatic breast cancer that is HER2 positive; to be used in combination with Xeloda; indicated for women who have received therapy with other cancer drugs.
TekturnaTM – aliskiren – approved 3/6/2007
For the treatment of hypertension.
VyvanseTM – lisdexamfetamine dimesylate – approved 2/23/2007
For the treatment of attention deficit hyperactivity disorder.
