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FDA Actions in Brief February 2012 (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
Glucarpidase (Voraxaze, BTG International) was approved for the treatment of patients with toxic levels of blood due to kidney failure.
A product label update for natalizumab (Tysabri, Biogen Idec, Elan) was approved that will help enable individual benefit-risk assessment for patients with multiple sclerosis. The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy.
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (Prevnar 13, Pfizer) was approved as a single dose for use in adults aged 50 years and older as a new indication. Prevnar is indicated for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine.
Fentanyl sublingual spray (Subsys, INSYS Therapeutics), a sublingually-administered formulation of fentanyl in a novel delivery device, was approved for the treatment of adults who experience episodes of breakthrough cancer pain.
Bortezomib (Velcade, Takeda) was approved to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least 1 prior therapy.
A label expansion was approved for self-administration of C1 esterase inhibitor (human) (Berinert, CSL Behring), a pasteurized, nanofiltered therapy for the treatment of acute attacks of hereditary angioedema (HAE). With appropriate training from a physician, patients can now self-administer Berinert by intravenous infusion. As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks.
Azilsartan medoxomil and chlorthalidone (Edarbyclor, Takeda) was approved for the treatment of hypertension to lower blood pressure in adults. Edarbyclor is the only fixed-dose therapy in the United States to combine an angiotensin II receptor blocker with the diuretic chlorthalidone in a once-daily, single tablet.
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.
