Recent FDA action (through, October 2010) related to Qnexa, Linjeta, JZP-6, Bydureon, Zalbin, Staccato loxapine, Tapentadol extended-release oral analgesic, AVP-21D9, 1% tenofovir vaginal gel, AFM 13, hGH-CTP, Rozrolimupab, Nefecon, SB1518 JAK2 inhibitor.
Complete response
• Phentermine/topiramate (Qnexa, Vivus) controlled-release capsules for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with comorbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity.
• Human insulin [rDNA origin] (Linjeta, Biodel) injection 100 IU/mL for the treatment of type 1 and type 2 diabetes mellitus
to improve glycemic control.
• Exenatide extended-release for injectable suspension (Bydureon, Amylin, Lilly, and Alkermes) for the once-weekly treatment of type 2 diabetes.
• Albinterferon alfa-2b (Zalbin, Human Genome Sciences and Novartis) 900 µg for the treatment of chronic hepatitis C. HGS and Novartis have decided not to develop this drug further.
• AZ-004 (Staccato loxapine, Alexza Pharmaceuticals), submitted as Adasuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg, for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
• Tapentadol extended-release oral analgesic (Johnson & Johnson) tablets for the treatment of moderate to severe chronic pain in patients aged 18 years or older.
Fast-track designations
• AVP-21D9 (Emergent BioSolutions) for the treatment of inhalational anthrax.
• 1% tenofovir vaginal gel (Conrad, a division of the Eastern Virginia Medical School) for the prevention of HIV and herpes infection in women.
Orphan drug designations
• AFM 13 (Affimed Therapeutics) for the treatment of Hodgkin lymphoma.
• hGH-CTP (Prolor Biotech) for the treatment of growth hormone deficiency in adults and children.
• Rozrolimupab (Sym001) (Symphogen and Swedish Orphan Biovitrum) for the treatment of primary immune thrombocytopenia.
• Nefecon (PL-56) (Pharmalink AB) for the treatment of IgA nephropathy, or Berger's Disease.
• SB518 JAK2 inhibitor (S*BIO) for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF).
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.