Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.
Complete response
• Oxycodone (Remoxy, Pfizer and Pain Therapeutics) extended-release capsules CII for the relief of moderate-to-severe pain requiring continuous, around-the-clock opioid treatment.
Recommended for approval
• Icatibant (Firazyr, Shire) for the treatment of acute attacks of hereditary angioedema in patients aged 18 years and older.
Priority review
• Eculizumab (Soliris, Alexion) for the treatment of atypical hemolytic uremic syndrome.
Fast-track designations
• Asimadoline (Tioga Pharmaceuticals) for the treatment of irritable bowel syndrome.
• Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant (NuThrax, Emergent BioSolutions) for the treatment of anthrax.
• SBC-102 enzyme replacement therapy (Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency.
Orphan drug designations
• Ciprofloxacin for inhalation (Aradigm) for the management of bronchiectasis.
• Mitosol (Mobius Therapeutics) for the prevention of corneal haze following surface ablation laser keratectomy.
• MORAb-004 and MORAb-066 (Morphotek) for the treatment of soft-tissue sarcoma and pancreatic cancer, respectively.
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.