FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.
FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
There's growing uncertainty about how the Obama healthcare reform program will be implemented, and how proposed changes will affect biomedical product development and coverage of prescription drugs.
Investigators question whether the thiazide diuretic, hydrochlorothiazide, should be used as commonly as it is for treating hypertension, according to a report published in a recent edition of the Journal of the American College of Cardiology.
Recent FDA Approvals (through March 2011) related to Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist
Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator that has been FDA approved for the treatment of systemic lupus erythematosus. It is the first new drug for the treatment of SLE approved in more than 50 years.
Patients using brand-name or generic antidepressant medications to treat major depressive disorder have similar drug discontinuation rates and accrue comparable healthcare costs during the first 6 months of treatment, according to a study published in March 2011 in the Journal of Managed Care Pharmacy.
Recent FDA action (through, March 2011) related to Salix, Protalix, Amyvid, indacaterol, Istodax, Mucin 1 targeting peptide GO-203-2c, Intercept plasma, Lomitapide, Liver cell therapy.
New molecular entity: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine was approved by FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years.
In a new study published ahead of print on the Mayo Clinic Proceedings website, researchers demonstrated that the cost of medications was a factor influencing the proportion of patients with heart failure who had poor medication adherence to beta-blockers, angiotensin converting-enzyme inhibitors or receptor blockers, and statins.
The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.
Overall, it would not appear that the new erythropoiesis-stimulating agents for treatment of cytopenia will add substantially to pharmacy budgets. As they are approved by FDA, each medication will need to be reviewed to understand its complete clinical advantage, and the safety profile will need to be completely understood.
New indication: Hydroxyprogesterone caproate injection was approved by FDA in February to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth.
An update on the management of atrial fibrillation issued by a task force consisting of the American College of Cardiology Foundation, the American Heart Association, and the Heart Rhythm Society has incorporated dabigatran into its recommendations.
Despite advancements, treatment of metastatic breast cancer hinges on multifarious factors and numerous unanswered questions about therapy linger. Agents that are highly active in heavily pretreated patients are needed to optimize outcomes in patients with metastatic disease. This article reviews current and novel treatment options for metastatic breast cancer.
FDA approved belimumab (Benlysta, Human Genome Sciences and GlaxoSmithKline) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy.
The managed care industry is missing a potentially rich opportunity to draw in consumers with the message that health insurance provides protection and peace of mind for the healthy as well as the sick.
States face huge budget deficits in the coming months, threatening their ability to maintain health, education and public safety programs.
It's not uncommon for bias and inaccuracies to infiltrate consumer health information and influence members' opinions about the healthcare they receive
Adults without health insurance are more likely to have undiagnosed hypercholesterolemia and hypertension than those with health insurance
With technology seemingly taking over the healthcare field, managed care organizations are thinking of innovative ways to reach out to consumers.
Blue Cross Blue Shield of Massachusetts has seen a rapid uptake of its new quality-based reimbursement structure
Forty-nine states have begun the activity necessary to have health insurance exchanges operational by 2014.
When major provisions of the Patient Protection and Affordable Care Act take place in 2014, MCOs will face new limits on premium rates in the individual and small-group markets.
Value is king. But in today's healthcare environment, value relies on refined quality measurements and innovative payment models.
Flexibility in response to market pressures has made PPOs the most popular type of managed care organization model.
Many states have to enact legislation authorizing the establishment of an exchange
FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.
The use of angiotensin-receptor blockers alone are not associated with increased odds of cancer or cancer-related death, according to a meta-analysis published in a recent edition of Lancet Oncology.