Recent FDA Approvals (through January 2013) related to (Deferasirox, Exjade, Novartis, bevacizumab, Avastin, Roche Group, trivalent influenza vaccine, Flublok, Protein Sciences, Budesonide, Uceris, Santarus, pooled plasma blood product, Octaplas, Octapharma, Sumatriptan iontophoretic transdermal system, Zecuity, NuPathe, onabotulinumtoxinA, Botox, Allergan
Deferasirox (Exjade, Novartis) was approved to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
A new indication for bevacizumab (Avastin, Genentech, a member of the Roche Group) was approved in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy after their cancer worsens (second-line treatment).
The first trivalent influenza vaccine (Flublok, Protein Sciences) was approved made using an insect virus (baculovirus) expression system and recombinant DNA technology for the prevention of seasonal influenza disease in people aged 18 to 49 years.
Budesonide (Uceris, Santarus and Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals SpA) extended-release tablets were approved for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Pooled plasma blood product (Octaplas, Octapharma) was approved for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficent levels.
Sumatriptan iontophoretic transdermal system (Zecuity, NuPathe) was approved for the acute treatment of migraine with or without aura in adults. It also provides relief of both migraine headache pain and migraine-related nausea.
FDA expanded the approved use onabotulinumtoxinA (Botox, Allergan) to treat adults with overactive bladder (OAB) who cannot use or do not adequately respond to anticholinergics.
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.