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FDA Actions in Brief February 2013
Recent FDA Approvals (through February 2013) related to (Ado-trastuzumab, Kadcyla, Genentech, Everolimus, Zortress, Novartis, Adapalene, benzoyl peroxide, Epiquo, Galderma, pomalidomide, Pomalyst, Celgene, alogliptin, Nesina, Takeda Pharmaceuticals, Kazano, Oseni, imatinib, Gleevec, mesalamine, Delzicol, Warner Chilcott, mipomersen sodium, Kynamro, Genzyme, Isis Pharmaceuticals, Merck, Oxutrol for Women, glycerol phenylbutyrate, Ravicti, Hyperion Therapeutics, pneumococcal 13-valent Conjugate Vaccine, Prevnar 13, Pfizer
Ado-trastuzumab emtansine (Kadcyla, Genentech, a member of the Roche Group) was approved for patients with HER2-positive, metastatic breast cancer.
Everolimus (Zortress, Novartis) was approved to prevent organ rejection in adult liver transplant patients.
Adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) was approved to treat acne in children aged 9 and older.
Pomalidomide (Pomalyst, Celgene) was approved to treat patients who have received at least 2 prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Alogliptin (Nesina, Takeda Pharmaceuticals), alogliptin and metformin hydrochloride (Kazano, Takeda Pharmaceuticals), and alogliptin and pioglitazone (Oseni, Takeda Pharmaceuticals) were approved for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
Imatinib (Gleevec, Novartis) was approved for the treatment of children newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia.
Mesalamine (Delzicol, Warner Chilcott) 400-mg delayed-release capsules were approved for the treatment of ulcerative colitis.
Mipomersen sodium (Kynamro, Genzyme and Isis Pharmaceuticals) once-a-week injection as an addition to lipid-lowering medications and diet was approved to treat patients with homozygous familial hypercholesterolemia.
Over-the-counter Oxytrol for Women (Merck) was appoved for treatment of overactive bladder in women aged 18 years and older.
Glycerol phenylbutyrate (Ravicti, Hyperion Therapeutics) was approved for the chronic management of some urea cycle disorders in patients aged 2 years and older.
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (Prevnar 13, Pfizer) was approved for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a 1-time dose to patients who have never received Prevnar 13.
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.
