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  USA Approved Drugs 2012

New Drugs 2012

Abthrax for inhalational anthrax

Abthrax (Raxibacumab) GlaxoSmithKline - The FDA has approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab's effectiveness for inhalational anthrax was demonstrated in one study in monkeys and three studies in rabbits. All animals were administered aerosolized B. anthracis spores, and efficacy was determined by survival at the end of the studies. More animals treated with raxibacumab lived compared to animals treated with placebo, sixty-four percent of animals in a monkey study and 44 percent of animals in one rabbit study compared with none in the placebo groups. Another study in rabbits showed that 82 percent of animals treated with antibiotics and raxibacumab survived exposure to anthrax compared with 65 percent of animals receiving antibiotic treatment alone.The safety of raxibacumab was evaluated in 326 healthy human volunteers. Common side effects included rash, extremity pain, itching and drowsiness.
Approved: December 14, 2012

Afinitor for advanced breast cancer

Afinitor (Everolimus) Novartis - The FDA approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. The safety and effectiveness of Afinitor was evaluated in a clinical study of 724 patients with advanced breast cancer. All patients had experienced menopause, had estrogen receptor-positive, HER2-negative breast cancer that had spread, and had previously received treatment with Femara or Arimidex. Patients were selected to receive either Afinitor in combination with Aromasin or Aromasin with a placebo (sugar pill). Patients who were assigned to receive Afinitor plus Aromasin combination had a 4.6 month improvement in the median time to disease progression or death compared to patients receiving the placebo plus Aromasin. Common side effects were mouth ulcers, infections, rash, fatigue, diarrhea and decreased appetite. Patients aged 65 years and older should be monitored closely as these patients experience a higher rate of serious side effects than younger patients receiving the treatment. The FDA has previously approved Afinitor for other cancers.
Approved: July 20, 2012

Aubagio for multiple sclerosis

Aubagio (Teriflunomide)Sanofi-Adventis - The FDA has approved this new drug for the treatment of relapsing forms of multiple sclerosis. In the primary clinical trial, the relapse rate of this drug given by mouth was 30% lower than those patients given placebos. The most common side effects are: diarrhea, abnormal liver function tests, nausea, and hair loss. There is a boxed warning to alert prescribers to the risk of liver problems including death and to a risk of birth defrects.
Approved: September 12, 2012 

Belviq for Obesity

Belviq (Lorcaserin) - Arena Pharmaceuticals - Belviq represents a significant breakthrough in the treatment of those significantly obese individuals in whom a healthy diet alone was not able to achieve significant weight loss. The pharmacology is not completely understood but it activates the serotonin 2C receptor in the brain which works to product a feeling of fullness. In a large clinical study one year after it had begun, 47.1 % of patients experienced a 5% weight loss compared with 23% taking placebo. A 10% weight loss was seen in 22% compared to 9% on placebo. The most common adverse reactions for non-diabetic patients (greater than 5% and more commonly than placebo) treated with BELVIQ compared to placebo were headache, dizziness, fatigue, nausea, dry mouth, and constipation. Diabetic patients also had an increased incidence of hypoglycemia.
Approved: June

Bosulif for chronic mylogenous leukemia

Bosulif (Bosutinib)Pfizer - Bosulif is intented for the treatment of chronic, acclerated or blast phase Philadelphia chromosome positive chronic mylogenous leukemia (CML) patients who are resistant to other therapies or cannot tolerate them. This belongs to a class called tyrosine kinase inhibitors. Tyrosine kinase is a critical intracellular enzyme required for cell fgrowth. A clinical study showed that 34% of patients resistant to other therapy experienced a major cytogenic response afer Bosulif. No data was given to be able to evaluate the impact of this on CML progression in treated patients. Side effects are: diarrhea, nausea, a decreased platelet level in the blood, vomiting, rash, fever and tiredness.
Approved: September 4, 2012

Bydureon for Type 2 diabetes

Bydureon (Exenatide) - Amylin Pharmaceuticals - this new addition to the drugs to control blood glucose levels in diabetic patients. It is unique in that following an injection, its hypoglycemic effects last for 1 week. Because of the findings in animal studies Amylin has created a registry for the purpose of determining whether Bydureon may produce medullary thyroid cancer.
Approved January 27, 2012

Cometriq for thyroid cancer

Cometriq (Cabozantinib) - Astra-Zeneca - Cometriq is the 2nd drug approved by the FDA to treat medullary thyroid cancer which has spread to other parts of the body (metastatic). It is a protein kinase inhibitor which blocks the production of abnormal proteins by cancerous thyroid cells thus impeding their growth. In a clinical study, patients receiving Cometriq lived an average of 11.2 months without tumor growth compared with 4 months in those receiving placebo. However, despite inhibition of tumor growth there was no difference in life span between Cometriq and placebo-treated patients! Side effects are: diarrhea, sores in mouth, swelling of hands and feet, weight loss, loss of hair color, bad taste, abdominal pain and constipation.
Approved: November 29, 2012 

Cystaran for corneal cysteine accumulation

Cystaran (cysteamine ophthalmic solution) - Sigma Tau - Cystaran has been approved for the treatment of patients suffering from corneal cystine crystal accumulation as a result of cystinosis (an abnormal level of cysteine in the blood). Cysteamine is a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis. The clinical safety and efficacy of CYSTARANTM was previously evaluated in controlled clinical trials conducted by the NIH, in approximately 300 patients. Results of these studies support the use of ophthalmic cysteamine as an effective treatment of corneal cystine crystals. The most frequently reported ocular adverse reactions, occurring in ≥ 10% of patients, were sensitivity to light, redness, eye pain/irritation, headache and visual field defects.
Approved: July 20, 2012

Eleyso for Gaucher Disease

Eleyso (Taliglucerase) - Pfizer and Protalix Biotherapeutics - This is a significant and unique addition to the drugs used to treat Gaucher disease, a genetic disorder in which a person lacks an enzyme called glucocerebrosidase. Symptoms may include: Bone pain and fractures and cognitive impairment. Clinical studies have shown that Eleyso given intravenously is an effective replacement for the deficient glucocerebrosidase thus lessening the symptoms and slowing the progression of that disease. Side effects were most commonly related to the infusion and included headache, chest pain, fatigue, increased blood pressure and joint pain. This drug has restricted distribution in the United States.
Approved: May

Eliquis for prevention atrial fibrillation-induced blood clots

Eliquis (Apixaban) - Bristol-Myers Squibb - The FDA approved the anti-clotting drug Eliquis (apixaban), an oral tablet used 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. The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin. As with other FDA-approved anti-clotting drugs, side effect include bleeding, including life-threatening and fatal bleeding.
Approved: December 28, 2012

Erivedge for Advanced Basal cell carcinoma

Erivedge (Vismodegib) - Genentech - Erivedge has been approved for locally advanced basal cell carcinoma patients who are not canadidates for surgery and/or radiation and for patients whose basal cell carcinoma has spread to other parts of the body. Taken by mouth, Erivedge acts by inhibiting the Hedgehog pathway. Activation of the hedgehog pathway is required for transition of the hair follicle from the resting to the growth phase. In a clinical study of 96 patients, 30% of those with metastatic disease experienced a partial response and 43% with locally advanced disease experienced a complete or partial response. Side effects were muscle spasms, hair loss, weight loss, nausea, change in sense of taste, decreased appetite, and fatigue.
Approved January 30, 2012

Fulyzaq for HIV/Aids diarrhea

Fulyzaq (Crofelemer) - Salix - The U.S. Food and Drug Administration approved Fulyzaq to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. In a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer, the median number of daily watery bowel movements was 2.5 per day. One clinical trial showed that 17.6 percent of patients taking Fulyzaq experienced clinical response compared with 8 percent taking placebo. Common side effects: upper respiratory tract infections, bronchitis, cough, flatulence, and increased levels of the liver enzyme bilirubin.
Approved December 31, 2012 

Fycompa for partial onset seizures

Fycompa (Perampanel) - Eisai - this new addition to the number of drugs has been approved for the prevention of partial seizures. FYCOMPA's approval was primarily based on three multi-center, randomized, double-blind, placebo-controlled studies. The studies demonstrated that FYCOMPA significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures. The most common adverse events (greater than or equal to 4 percent and greater than placebo) were dizziness, sleepiness, tiredness, irritability, falls, nausea, problems with muscle coordination, problems walking normally, vertigo and weight gain. Serious or life-threatening psychiatric (mental) problems were also seen more frequently in patients treated with FYCOMPA.
Approved: October 22, 2012

Gattex for short bowel syndrome

Gattex (Teduglutide) - NPS Pharmaceuticals - Short Bowel Syndrome (SBS) is a condition that results from the partial or complete surgical removal of the small and/or large intestine. Extensive loss of the small intestine can lead to poor absorption of fluids and nutrients from food needed to sustain life. As a result, patients with SBS often receive parenteral nutrition. Gattex is an injection administered once daily that helps improve intestinal absorption of fluids and nutrients, reducing the frequency and volume of parenteral nutrition. The clinical trials were designed to measure the number of patients who achieved at least 20 percent reduction in the volume of weekly parenteral nutrition after 20 and 24 weeks of treatment (clinical response). Forty-six percent and 63 percent of patients treated with Gattex achieved clinical response, versus 6 percent and 30 percent of patients treated with placebo. The most common side effects are: abdominal pain, injection site reactions, nausea, headaches, abdominal distension and upper respiratory tract infection. Patients treated with Gattex have a potential increased risk of developing cancer and abnormal growths (polyps) in the intestine, obstructions in the intestine, gallbladder disease, biliary tract disease and pancreatic disease.
Approved: Decmber 21, 2012

Horizant for restless Legs Syndrome

Horizant (Gabapentin) - GSK - Although previously approved for epilepsy and the pain associated with post-herpes nerve pain the treatment of restless leg syndrome (RLS) is a newly approved indication for this drug. The effectiveness of Horizant in RLS has been demonstrated in two separate studies. In one of them there was a 76% improvement in symptoms compared with 39% placebo. Side effects of drowsiness were observed in 20-27% of patients. Other side effects included: dizziness, headache, fatigue, irritability, vertigo and depression. This product is not interchangeable with gabapentin due to different pharmacokinetic profiles.
Approved: June

Inclusig for chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic leukemia

Inclusig (Ponatinib) - Ariad - Inclusig is approved for use in patients with chronic myeloid leukemia (CML) and also Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (Ph+ ALL) who have relapsed or are refractory to other therapies. Inclusig, to be taken once a day, blocks certain proteins that promote the development of cancerous cells and treats patients whose leukemia is resistant or intolerant to a class of drugs called tyrosine kinase inhibitors. For patients with chronic-phase CML the primary end point was a major cytogenetic response within 12 months of treatment, this was achieved in 55% of patients with chronic-phase CML. For patients with accelerated- phase the primary end point was a major hematologic response (normal white blood cell counts) within 6 months of treatment. This was achieved in 58% of patients with accelerated-phase. Side effects: the most common adverse effects were rash, abdominal pain, headache, dry skin, constipation, fatigue, pyrexia, nausea, arthralgia, and hypertension. There were cases of pancreatitis (6% of all patients), elevation of pancreatic enzymes and general bone marrow suppression. (thrombocytopenia in 42%, neutropenia in 34%, and anemia in 20%).
Approved: December 14, 2012

Inlyta for Advanced renal Cancer

Inlyta (Axitinib) - Pfizer - This is a useful addition to the limited number of drugs approved for the treatment of advanced kidney cancer. It acts by blocking intracellular kinases which are important in (cancer) cell growth. The results of one study showed that patients receiving Inlyta had a disease-free survival of 6.7 months compared with 4.7 months for those treated with sorafenib, the current standard. Side effects ovccurred in 20% of patients and consisted of diarrhea, high blood pressure, tiredness, loss of voice, hand-foot syndrome and weakness.
Approved January-Restricted

Jetrea for vitreomacular adhesions in the eye

Jetrea (Ocriplasmia) - ThromboGenics - Jetrea offers an alternative to virectomy surgery for patients with symptomatic vitreomacular adhesions (VMS's) of the eye. As expected, this medication which is given by injection into the eye has two major side effects. The first is classified under the umbrella of ocular adverse effects and include conjunctival hemorrhage, vitreous floaters, photopsia (flashes of ligh), and injection related pain. The overall incidence was 68.4% compared with 53.5% in the placebo group. The incidence of more serious ocular side effects was not significantly higher than for patients receiving the placebo injection.
Approved: October 18, 2012 

Juxtapid for familial hypercholesterolemia

Juxtapid (Lomitapide) - Aererion - Approved for use in patients exhibiting elevated cholesterol levels, this orally administered agent is specific for patients with the homozygous familial form of hypercholesterolemia. On average, LDL cholesterol levels fell by one-half in patients responding to this drug. Side effects: diarrhea, nausea, vomiting, indigestion and abdominal pain. There is a Boxed warning to the possibility of serious liver damage.
Approved: December 26, 2012

Kalydeco for cystic fibrosis

Kalydeco (Ivacaftor) - Vertex - this is the first drug specifically approved for the treatment of cystic fibrosis. It is effective only when patients with cystic fibrosis carry the G551D mutation in the CF membrane regulator (CFTR) gene. Although the number of children it may benefit is limited the fact that it is the first drug found to be effective albeit in a small number of patients is a significant forward step in treating this deadly disease.

Korlym for Cushings Syndrome

Korlym (Mifepristone) - Corcept Therapeutics - Korlym has been approved for the treatment of the high blood sugar levels in adults with endogenous Cushing's syndrome and is the first drug to be approved for that use. In a clinical trial of 50 patients there was a significant lowering of blood sugar levels and some patients had significant reductions in their insulin requirements. Common side effects included: nausea, fatigue, headache, swelling of the extremities and decreased appetite. There is a BLACK BOX warning that Korlym shoud not be used in pregnancy.
Approved 02/17/12

Kyprolis for multiple myeloma

Kyprolis (Carfilzomib) - Onyx - Multiple myeloma continues to be one of the cancers which advances in chemotherapy are marginal. Such is the case with Kyprolis. In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumor growth in models of multiple myeloma, hematologic, and solid tumors. The overall response rate in patients who had received at least two prior therapies was 23% and the median duration of response was 7.8 months. Side effects which are seen in over 30% of patients include: fatigue, low white blood cell count, shortness of breath, and heart failure.
Restricted distribution Approved July

Linzess for Chronic Constipation and Irritable Bowel Syndrome

Linzess (Linaclotide) - Forest-Linzess is a medication given by mouth approved for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome (IBS) in patients who do not respond to standard treatment. With abdominal pain a common symptom of both CIC and IBS, Linzess was significantly better in relieving abdominal pain than placebo and patients treated with Linzess experienced more complete bowel movements than did those taking placebo. The most common side effect was diarrhea.
Approved August

Marqibo for Acute Lymphocytic Leukemia

Marqibo (Vincristine Sulfate Liposome Injection) - Talon - This is a new dose form of an older anticancer drug. Placing it in a liposome allows for better penetration of the drug into the cancer dell. Approved for Philadelphia chromosome negative (Ph-) acute lymphocytic leukemia 15.4% of patients who received this treatment responded with a complete response or a complete remission with incomplete blood count recovery. Serious adverse effects were seen in 76% of patients and consisted of low white blood cell counts, low blood pressure, respiratory distress and cardiac arrest. More common side effects included: constipation, nausea, fever, nerve damage, fatigue, and insomnia. Approved August

Myrbetriq for Overactive Bladder

Myrbetriq (Mirabegron) - Astellas - Recently approved for the treatment of overactive bladder, Myrbetrig significantly reduced the number of times patients urinated and the number of times patients had wetting “accidents” in 24 hours. Its mechanism of action is to relax the detrusor smooth muscle of the bladder during the bladderfill-void cycle by activation of beta-3 adrenerigic receptor which increases bladder capacity. The most common side effects are: increased blood pressure, cold-like symptoms, constipation, tiredness, elevated heart rate and abdominal pain.
Approved: June

Neutroval for Neutropenia

Neutroval (Filgastim) - TEVA - This new injectable product has been approved for the treatment of chemotherapy-induced neutropenia. Clinical studies have demonstrated that compared with placebo, it produced clinically significant shortening of the duration of severe neutropenia in women undergoing chemotherapy for progressive cancer of the breast (1.1 days compared with 3.8 days). Adverse effects were limited to bone pain and excess production of white blood cells.

Omontys for anemia of chronic kidney disease

Omontys (Peginsatide) - Affymax - This is the first drug since 2001 to be approved for the treatment of anemia in patients undergoing hemodialysis for chronic kidney disease. It acts by stimulating the bone marrow to produce more red blood cells. Given subcutaneously every month, hemoglobin levels of 20-12g/dl were maintained in the majority of patients. The most common side effects were: diarrhea, vomiting , hypertension, and aching of the joints. 
Approved 03/27/12

Perjeta for late-Stage Breast Cancer

Perjeta (Pertuzmab) - Genentech - This is a significant new addition to the drugs available for the treatment of late-stage metastatic cancer of the breast. Perjeta is a HER-2 receptor antagonist. HER protein is believed to contribute to cancer growth. Clinical studies have shown that women treated with Perjeta and Perjeta in combination with trastuzumab and docetaxel experienced a progression free survival of 18.5 months compared with those receiving trastuzumab and docetaxel and placebo of 12.4 months. The most common side effects of Perjeta when used in combination with other drugs such as trastuzumab and docetaxel are: diarrhea, hair loss, lowered white blood cells, nausea, tiredness and peripheral nerve damage.
Approved June-Restricted Distribution

Picato for Actinic Keratosis

Picato (Ingenol mebutate) - Leo Pharma - This new medication is a gel approved for the treatment of actinic keratosis (AK). Actinic keratosis is a precancerous lesion which is associated with exposure to the sun and to aging skin. Left untreated, AK can progress to squamous cell cancer 65% of the time. In a large clinical trial a significantly higher number of patients had complete (37-47%) or partial (60-68%) remission than with a placebo gel (7-11%). The most common adverse reactions (≥2 %) are local skin reactions, application site pain, application site pruritus, application site irritation, application site infection, periorbital edema, nasopharyngitis and headache.
Approved: January

Qsymia for weight loss

Qsymia (Phenteramine and Topiramate) - Vivus - this is the first medication approved for the treatment of obesity in 14 years. This combination available as capsules, produced a weight loss of >5% body weight in 67% of patients and a weight loss of >10% in 47% of patients studied. It is only approved for patients with a body mass index of 30+ or a BMI of 27+. Common side effects include: numbness of extremities, dizziness, and dry mouth. Qsymia is contraindicated in pregnancy, presence of suicidal behavior, glaucoma and hyperthyroidism. Vivus currently has no program by which Qsymia can be made available to patients outside of the United States.
Approved: July 17, 2012

Situro for multi-resistant tuberculosis

Situro (Bedaquiline) Janssen - This is the first new drug approved for the treatment of tuberculosis in 40 years. Thus its importance is significant with the increasing problem of multi-drug resistant tuberculosis (MDR-TB). This drug, available as an oral preparation is indicated as an additional drug to be used in addition to the currently available drugs for the treatment of TB. It should not be used as the sole agent! A study of the effectiveness of Situro in combination with other anti-TB drugs found that the median time to sputum culture conversion to negative was 83 days compared to combination therapy without Situro of 125 days. Common side effects include: nausea, joint pain and headache. Situro may affect the electrical activity of the heart which could lead to a potentially fatal heart rhythm. Situro in the United States will be restricted to a single source provider and thus will be not available to patients outside of the United States for the immediate future.
Approved Dec. 31, 2012

SKlice for Head Lice

Sklice (ivermectin) - Sanofi Pasteur - This topically applied lotion has been approved for the treatment of head lice in children. In a comparison study with placebo, 71-76% of children treated with SKlice for ONE application were free of live lice 14 days later compared with 16-19% of children treated with placebo gel. Side effects were rare (<1%), local and consisted of : Skin burning sensation, dandruff, and eye irritation.
Approved: February

Stendra for Erectile Dysfunction

Stendra (Avanafil) - Vivus - This is a new addition to a number of drugs available for the treatment of erectile dysfunction. It, like others in its class, is a phosphodiesterase inhibitor. Side effects include: headache,redness of the eyes, nasal congestion, and back pain. Rarely it can cause vision changes. Like others it should not be used by men taking nitrates for angina.
Approved April

Stivarga for advanced colorectal cancer

Stivarga (Regorafeneib) - Bayer - Approved to treat patients with colorectal cancer that has progressed after treatment with other agents. Stivarga is a multi-kinase inhibitor that blocks a number of enzymes required for cancer cell growth. Patients treated with Stivarga experienced a delay in tumor growth (progression-free survival) for a median of 2 months compared with patients treated with placebo at 1.7 months. Patients receiving Stivarga lived for a median of 6.4 months compared with 5 months in those receiving placebo. Side effects: weakness, fatigue, loss of appetite, hand-foot syndrome, diarrhea, mouth sores, high blood pressure, changes in voice.
Approved September 27, 2012

Stribild for HIV infections

Stribild (Elvitegravir, cobicistat, emtricitabine, tenofir) - Gilead - This is a new 4-drug combination tablet approved for the tratement of patients with HIV infection who have never been treated with HIV medication before. The idea behind the four drug combination is to lessen the chances of resistant strains commonly found when treatment with fewer drugs has begun. After treatment with Stribild for 48 weeks, 88- 90% of treated patient had no detectable HIV virus in their blood.
Approved August

Surfaxin for Respiratory Distress Syndrome in Infants

Surfaxin (Lucinactant) - Discovery Laboratories - The FDA recently approved this unique drug for the syndrome of respiratory distress in newborns (RDS). Surfaxin is a synthetic surfactant. Normal lungs produce surfactant which coats the insides of the lungs and helps to keep the small airways open. Premature infants often do not produce enough natural surfactant to adequately coat their small airways. Suirfaxin mimics the natural surfactant and prevents those infants from developing RDS.
Approved 03/06/12

Synribo for chronic myelogenous leukemia

Synribo (Omacetaxine mepesuccinate) Teva - the FDA approved SYNRIBO is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). The mechanism of action of omacetaxine mepesuccinate has not been fully elucidated but includes inhibition of protein synthesis. The effectiveness of Synribo was evaluated by the percent of patients who experienced a normalization of white blood cell counts 14.3 for the acclerated phase CML and 18.4% for the Philadelphia chromosome positive CML patients. The duration of response was 4.7 months for the acclerated patients nad 12.5 months in the Philadelphia chromosome patients. Side effects were a low level of platelets (thrombocytopenia), red blood cells (anemia), white blood cells (neutropenia), lymphocytes (lymphopenia) infections, diarrhea and weakness.
Approved: October 26, 2012

Vascepa for Hypertriglyceridemia

Vascepa (Isosapent ethyl) - Amarin - This is the important addition to drugs approved for the treatment of severe hypertriglyceridemia. This preparation given by mouth reduced triglyceride levels by 27% in a placebo-controlled clinical trial compared with a 10% increase in patients taking placebo. The only adverse reaction which exceeded that of placebo was joint pain which was experienced by 2.3% of patients.
Approved July

Voraxaze for methotrexate toxicity

Voraxaze (Glucarpidase) - BTG International - It is a recombinent enzyme that rapidly converts methotrexate to a much less toxic metabolite. In one clinical study Voraxaze was able to reduce the methotrxate serum levels by 95%. Side effects included hypotension, headache, nausea, vomiting, flushing and extremity numbness.
Approved Jan. 27, 2012

Votrient for advanced soft tissue sarcoma

Votrient (Pazopanib) - GlaxoSmithKline - This newly FDA-approved drug is indicated to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues. The safety and effectiveness of Votrient was evaluated in a single clinical study in 369 patients with advanced soft tissue sarcoma who had received prior chemotherapy. Patients were randomly selected to receive Votrient or a placebo. The study was designed to measure the length of time a patient lived without the cancer progressing (progression-free survival). The disease did not progress for a median of 4.6 months for patients receiving Votrient, compared with 1.6 months for those receiving the placebo. The most common side effects are: fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor and muscle pain, hair color changes, headache, a distorted sense of taste, shortness of breath, and skin discoloration. Votrient carries a boxed warning alerting to the potential risk of liver damage (hepatotoxicity), which can be fatal. Patients should be monitored for liver function and treatment should be discontinued if liver function declines.
Approved: April 26, 2012

Xeljanz for rheumatoid arthritis

Xeljanz (Tofacitinib) - Pfizer - this newly approved medication is indicated for the treatment of moderate to severe active rheumatoid arthritis in patients who did not respond to methotrexate. In a number of controlled trials patients who received Xeljanz experienced an improvement in physical function compared with placebo injections. Side effects can be significant due to the fact that Xeljanz acts by suppressing the immune system. Among those the most significant is an increased risk of serious infections, other less serious side effects are: respiratory tract infections, headache, diarrhea, and nasal passage inflammation.
Approved: November 6, 2012

Xtandi for Prostate Cancer

Xtandi (Enzalutamide) - Astellas - This is a new addition to the drugs used to treat prostate cancer. In this case it is indicated for the treatment of late- stage(metastatic) castration-resistant disease. Xtandi is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. In one study men the overall survival rate in men receiving Xtendi was 18.4 months compared with 13.6 months in men who received placebo. The most common side effects include: weakness, fatigue, back pain, diarrhea, hot flushes, tingling sensation, and high blood pressure. Approximately 1% of treated patients had seizures.
Restricted distribution. Approved August

Zaltrap for Colorectal Cancer

Zaltrap (ziv-Afibercept) - Sanofi-Aventis -Zaltrap has been approved for the treatment of colo-rectal cancer which has spread to other parts of the body. It is to be used in combination with the Folfiri (folinic acid, fluorouracil, and irinotecan) regimen. Zaltrap is an angiogenesis inhibitor which reduces the blood supply to growing cancers thus slowing their growth. Its effect on overall survival is marginal with those receiving Zaltrap and Folfiri living an average of 13.5 months compared with 12 months in those receiving Folfiri and a placebo. Side effects are: decreased white blood cell count, diarrhea, mouth ulcers, fatigue, decreased appetite, and abdominal pain. Restricted distribution Approved August

Zioptan for glaucoma

Zioptan (Tafluprost) - Merck - this newly approved medication joins a number of other drugs approved for open-angle glaucoma. The fact it does not contain a preservative is an advantage over others in its therapeutic field.
Approved 02/13/12

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