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FDA Actions in Brief July 2012
Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)
Phentermine and topiramate extended-release (Qsymia, Vivus) was approved as an addition to a reduced-calorie diet and exercise for chronic weight management. It is approved for use in adults with a body mass index (BMI) of 30 kg/m2 or greater (obese) or adults with a BMI of 27 kg/m2 or greater (overweight) who have at least 1 weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
Once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences), in combination with safer sex practices, was approved to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
First over-the-counter HIV test (OraQuick, Orasure) was approved to detect the presence of HIV in saliva collected using a mouth swab.
Sodium picosulfate, magnesium oxide, and citric acid (Prepopik, Ferring Pharmaceuticals) was approved to help cleanse the colon in adults preparing for colonoscopy.
Cetuximab (Erbitux, Eli Lilly and Bristol-Myers Squibb) in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) was approved for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. Concurrently, the first KRAS companion diagnostic test (therascreen, Qiagen) was approved.
Mirabegron (Myrbetriq, Astellas Pharma US) was approved to treat adults with overactive bladder.
Viral-load test (COBAS AmpliPrep/COBAS TaqMan CMV Test, Roche Molecular Systems) was approved to help healthcare professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
Lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) was approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes).
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
