NEW
DRUG APPROVALS by Shamna.M
· Lymphoseek
March 13, 2013 -- The U.S. Food and
Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept)
Injection, a 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. Lymph nodes filter lymphatic
fluid that flows from the body’s tissues. This fluid may contain cancer cells,
especially if the fluid drains a part of the body containing a tumor. By
surgically removing and examining the lymph nodes that drain a tumor, doctors
can sometimes determine if a cancer has spread. Lymphoseek is an imaging drug
that helps locate lymph nodes; it is not a cancer imaging drug. Lymphoseek is
the first new drug used for lymph node mapping to be approved in more than 30
years. Other FDA-approved drugs used for lymph node mapping include sulfur
colloid (1974) and isosulfan blue (1981).
· Abilify Maintena
FDA Approves Once-Monthly Abilify Maintena (aripiprazole) for
Extended-Release Injectable Suspension for the Treatment of Schizophrenia.
It is the firswt Dopamine D2 partial agonist approved as a once-monthly
injection. It contributes a new treatment option to address the ongoing need
for relapse prevention in patients with Schizophrenia.
· Vituz
Pernix Therapeutics Receives FDA Approval for Vituz Oral
Solution (hydrocodone bitartrate and chlorpheniramine maleate). Vituz is
indicated for the relief of cough and symptoms associated with upper
respiratory allergies or a common cold in adults 18 years of age and older.
·
Kadcyla
February 22, 2013 -- The U.S. Food and Drug Administration
approved Kadcyla (ado-trastuzumab emtansine), a new therapy for
patients with HER2-positive, late-stage (metastatic) breast cancer. HER2 is a
protein involved in normal cell growth. It is found in increased amounts on
some types of cancer cells (HER2-positive), including some breast cancers. In
these HER2-positive breast cancers, the increased amount of the HER2 protein
contributes to cancer cell growth and survival. Kadcyla is intended for
patients who were previously treated with trastuzumab, another anti-HER2
therapy, and taxanes, a class of chemotherapy drugs commonly used for the
treatment of breast cancer.
·
Pomalidomide (Pomalyst)
February
8, 2013, the U. S. Food and Drug Administration granted accelerated approval to
pomalidomide (POMALYST capsules, Celgene Corporation) for the treatment of
patients with multiple myeloma who have received at least two prior therapies,
including lenalidomide and bortezomib, and have demonstrated disease
progression on or within 60 days of completion of the last therapy.
· Delzicol
Feb. 5, 2013 -- United States Food and
Drug Administration (FDA) has approved its new 400 mg mesalamine product
indicated for the treatment of ulcerative colitis. The product will be marketed
as Delzicol (mesalamine) 400 mg delayed-release capsules.
· Ravicti
February 1, 2013 -- The U.S. Food and
Drug Administration approved Ravicti (glycerol
phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs)
in patients ages 2 years and older. UCDs are genetic disorders that involve
deficiencies of specific enzymes involved in the urea cycle, a series of
biochemical steps normally required to remove ammonia from the blood. When
protein is absorbed and broken down by the body, it produces nitrogen as a
waste product. The urea cycle removes nitrogen from the blood and converts it
to urea, which is removed from the body through urine. In people with UCDs,
nitrogen accumulates and remains in the body as ammonia, which can travel to
the brain and cause brain damage, coma or death. Ravicti, a liquid taken three
times a day with meals, helps dispose of ammonia in the body. It is intended
for patients whose UCD cannot be managed by a protein-restricted diet or amino acid
supplements alone. It must be used with a protein-restricted diet and, in some
cases, dietary supplements.
·
Kynamro
January 29, 2013 -- The U.S. Food
and Drug Administration approved Kynamro (mipomersen sodium) injection as an addition to
lipid-lowering medications and diet to treat patients with a rare type of high
cholesterol called homozygous familial hypercholesterolemia (HoFH). The
addition of Kynamro helps to reduce low-density lipoprotein-cholesterol
(LDL-C), apolipoprotein B, total cholesterol, and non-high density
lipoprotein-cholesterol (non HDL-C). HoFH, an inherited condition that affects
about one out of every one million people in the United States, occurs when the
body is unable to remove LDL-C, often called “bad” cholesterol, from the blood
causing abnormally high levels of circulating LDL-C. For those with HoFH, heart
attacks and death often occur before age 30. Kynamro is an orphan drug
approval, meaning it was developed to treat a disorder affecting fewer than
200,000 people. In December 2012, the FDA approved Juxtapid (lomitapide) to
reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients
with HoFH.
February 26, 2013 -- Osphena (ospemifene) is an estrogen
agonist/antagonist indicated for the treatment of moderate to severe
dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.
January 25, 2013 -- Nesina (alogliptin) is a dipeptidyl
peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.
January 25, 2013 -- Oseni (alogliptin and pioglitazone) is a
dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione fixed-dose
combination for the treatment of type 2 diabetes.
January 25, 2013 -- Kazano (alogliptin and metformin) is a
dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide antihyperglycemic
fixed-dose combination for the treatment of type 2 diabetes.
January 25, 2013 -- Oxytrol for Women (oxybutynin) is a
muscarinic receptor antagonist transdermal patch available over-the-counter for
the treatment of overactive bladder in women.
January 17, 2013 -- Zecuity (sumatriptan iontophoretic
transdermal system) is a serotonin (5HT) 1b/1d receptor agonist (triptan)
indicated for the acute treatment of migraine.
·
Octaplas (pooled plasma (human)) Solution for Intravenous
Infusion
January 17, 2013 -- Octaplas is a solvent/detergent (S/D)
treated, pooled human plasma indicated for the replacement of multiple
coagulation factors in patients with acquired deficiencies and plasma exchange
in patients with thrombotic thrombocytopenic purpura.
January 16, 2013 -- FluBlok (influenza vaccine, recombinant
hemagglutinin) is an influenza vaccine indicated for active immunization of
adults against seasonal influenza.
January 14, 2013 -- Uceris (budesonide) is a
glucocorticosteroid indicated for the induction of remission in patients with
active, mild to moderate ulcerative colitis.
January 9, 2013 -- Skyla (levonorgestrel) is a
progestin-containing intrauterine system (IUS) indicated for prevention of
pregnancy for up to three years.
December 31, 2012 -- Fulyzaq (crofelemer) is a
proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS
patients taking antiretroviral therapy.
December 28, 2012 -- Eliquis (apixaban) is a factor Xa
inhibitor anticoagulant indicated to reduce the risk of stroke and systemic
embolism in patients with nonvalvular atrial fibrillation.
December 28, 2012 -- Sirturo (bedaquiline) is an oral
diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary
multi-drug resistant tuberculosis.
FDA Approves 'Bionic Eye' to Help Against Rare Vision
Disorder
THURSDAY Feb. 14, 2013 – Officials
announced that an implanted, sight-enhancing device some are calling a
"bionic eye" is the first to gain approval for use in the United
States. According to the U.S. Food and Drug Administration, the new Argus II
Retinal Prosthesis System can help patients with a genetic eye disease called
retinitis pigmentosa regain some sense of vision. About 100,000 Americans are
believed to be affected by the illness, which causes a gradual deterioration of
the eyes' photoreceptor cells. The new device uses a tiny video camera attached
to eyeglasses that transmits images to a sheet of electrode sensors that have
been sewn into the patient's eye. These sensors then transmit those signals to
the brain via the optic nerve. The device helps replace the damaged cells of
the retina and helps patients see images or detect movement.
FDA Panel to
Consider Brain Stimulator for Epilepsy
THURSDAY Feb. 21, 2013 - A U.S. Food and Drug
Administration advisory panel will weigh the merits of a new therapy for some
people with epilepsy who have seizures that don't respond to medication. Smaller
and thinner than an implantable defibrillator, the battery-powered,
programmable device, called the RNS System, is placed just under the skull
during surgery. Electrodes reach from the device to the one or two places in
the patient's brain that create the abnormal electrical activity that causes
seizures. The device works by short-circuiting nerve cells in that area to
normalize brain activity bef
The first symptoms of retinitis pigmentosa usually occur in early childhood, when both eyes typically are affected. It reduces the power of eyes. People may face loss of vision. Many people finding proper treatment of this disease. To find about retinitis pigmentosa treatment visit online sites and also consult with a doctor.
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