"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing.
Formulary Watch
Latest News
Today's Top Stories
All News
Advertisement
New indication: Rifaximin (Xifaxan) was approved in March 2010 for the reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.
FDA granted marketing approval for a new formulation of controlled-release oxycodone (OxyContin, Purdue Pharma) on April 5, 2010.
New Formulation: Doxepin (Silenor) was approved in March 2010 for the treatment of insomnia.
According to a systematic review in the April 13, 2010 edition of the Journal of the American Medical Association, noninsulin antidiabetic drugs show similar reductions in glycosylated HbA1c when used in combination with metformin in type 2 diabetics, but differ in their rates of hypoglycemia and weight gain.
Clinical studies of patients with both ST-elevation and non-ST-elevation acute coronary syndromes have shown that ticagrelor, when compared with clopidogrel, reduces the rates of vascular death and myocardial infarction while increasing the rate of non-coronary artery bypass graft-related major bleeding. Ticagrelor was also associated with a higher incidence of dyspnea and ventricular pauses.
Generic drugs approved by FDA (through April 2010): Losartan potassium tablets in 25-mg, 50-mg, and 100-mg, Losartan potassium and hydrochlorothiazide tablets in 50 mg/12.5 mg, 100 mg/12.5-mg, and 100 mg/25 mg, Hydromorphone hydrochloride injection, Mesna injection
Recent FDA approvals (through April 2010) related to Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig
Guideline-specific management of atrial fibrillation; Focus on ticagrelor; Agents in late-stage development for the treatment of epilepsy and seizure disorders
Despite being known teratogenic agents contraindicated in pregnancy, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs) are being increasingly prescribed to women with hypertension during their childbearing years.
Advertisement
A clinical study showed patients who switched from exenatide twice daily to liraglutide once daily experienced further reductions in hemoglobin A1c and weight loss when added to oral antidiabetes drugs (OADs).
Antidepressants can help depressed patients with physical illness, and healthcare professionals should consider them more often, new research underscores.
Patients with acute coronary syndrome (ACS) who undergo coronary artery bypass graft (CABG) surgery are less likely to develop fatal outcomes when given ticagrelor instead of clopidogrel as an antiplatelet medication, new research indicates.
Physicians who check the DNA of patients before initiating warfarin therapy are more likely to provide the correct dose, avoiding the possibility of readmittance to a hospital.
Reducing cardiovascular risk is patients with type 2 diabetes: management of dyslipidemia; Focus on naproxicond; Drug Watch: Agents in late-stage development for the treatment of hepatitis C
On March 12, 2010, FDA announced that the manufacturers of clopidogrel, an antiplatelet agent given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease, will be placing a new black box warning into the drug's prescribing information.
New molecular entity: Velaglucerase alpha for injection (VPRIV) was approved February 2010 as an enzyme replacement therapy for the long-term treatment of type 1 Gaucher disease in pediatric and adult patients.
A randomized controlled trial of recent stroke survivors found that patients receiving the selective serotonin reuptake inhibitor escitalopram had greater improvement in global cognitive function than those receiving placebo or Problem Solving Therapy.
Generic drugs approved by FDA (through February 2010): Tamsulosin hydrochloride capsules, 0.4 mg, Imiquimod cream, 5%, Diltiazem hydrochloride extended-release tablets
Cardiovascular disease (CVD) remains the leading cause of death in patients with diabetes mellitus, accounting for 50% of all deaths. Dyslipidemia is an important modifiable risk factor in diabetic patients and represents a key area for intervention in these patients. Diabetic patients have a lipid profile characterized by low high-density lipoprotein cholesterol (HDL-C) levels and an increase in triglyceride levels. Diabetics have increased numbers of low-density lipoprotein cholesterol (LDL-C) particles but with a shift to smaller, denser LDL-C particles. The net effect is that patients with type 2 diabetes do not have substantially higher LDL-C concentrations than patients without diabetes.
New molecular entity: Dalfampridine (Ampyra) was approved in January 2010, as a treatment to improve walking in patients with multiple sclerosis.
Naproxcinod, a cyclooxygenase-inhibiting nitric oxide donor, is pending FDA approval for the indications of knee and hip osteoarthritis. Treating osteoarthritis pain can be challenging because many agents commonly used for this indication carry potential risk for increased cardiovascular events including increased blood pressure, increased upper gastrointestinal bleeding, and increased hepatotoxicity.
New added financial incentives are slated to drive adoption of electronic health record systems by doctors and hospitals, and increased government funding may finally lead to standards for interoperability and e-health exchanges necessary for the free flow of secure health data.
Recent FDA approvals (through April 2010) related to Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox
Agents in late-stage development for the treatment of hepatitis C.
Results from a Phase 3 trial by Sanofi-aventis have shown that the investigational compound, cabazitaxel, and prednisone/prednisolone markedly enhanced overall and progression-free survival in patients with metastatic hormone-refractory prostate cancer where the disease advanced after treatment with docetaxel-based chemotherapy.
Advertisement
Advertisement
Trending on Managed Healthcare Executive
1
FAQ: The uncertain future of enhanced ACA premium subsidies and what it means for U.S. healthcare
2
What UnitedHealth Group’s earnings call reveals about managed care trends
3
Could GLP-1s help with cognitive symptoms, pychosis of schizophrenia?
4
Medicaid tech companies pledge $600 million to help states update systems
5