Recent FDA Approvals (through August/September 2010) related to Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz.
Fingolimod (Gilenya, Novartis) was the first approved oral treatment indicated for relapsing forms of multiple sclerosis.
Denosumab (Prolia, Amgen) was approved for the treatment of postmenopausal women with osteporosis at high risk for fracture.
Pegloticase (Krystexxa, Savient) was approved for the treatment of gout in adult patients refractory to conventional therapy.
Pralidoxime chloride (Protopam Chloride, Baxter Healthcare) was approved for the treatment of pesticide poisoning in children.
Dexamethasone intravitreal implant (Ozurdex, Allergan) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.
Buprenorphine and naloxone (Suboxone Film, Reckitt Benckiser Pharmaceuticals) sublingual film (C-III) was approved for the maintenance treatment of opioid dependence.
Asenapine (Saphris, Merck) sublingual tablets was approved for expanded indications and is now indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Aliskiren and amlodipine (Tekamlo, Novartis) single tablet was approved for the treatment of high blood pressure.
Estrogen/progestin combined oral contraceptive tablets that also contain a folate (levomefolate calcium 0.451 mg) (Beyaz, Bayer HealthCare) was approved for the prevention of pregnancy; treatment of symptoms of premenstrual dysphoric disorder in women who choose to use an oral contraceptive for contraception; and treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.
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.