Recent FDA action (through August 2012) related to, ferric carboxymaltose injection, Injectafer, abiraterone acetate, Zytiga, cabozantinib, Exelixis, eltrombopag, Promacta, AEZS-130 oral ghrelin agonist, inhaled nitric oxide, GeNO LLC, gevokizumab, XOMA, calcipotriene cream, Dovonex, montelukast sodium, Singulair, lidocaine topical patch 5%, Lidoderm, filgrastim, Neupogen
Complete response
■ Ferric carboxymaltose injection (Injectafer, Luitpold Pharmaceuticals) for the treatment of iron deficiency anemia. In the complete response letter (CRL) FDA said that its decision to withhold approval at this time was not related to any issues with the Injectafer NDA filing, but with Luitpold's manufacturing facility in Shirley, N.Y. During a recent inspection, issues in the manufacturing facility were noted by FDA inspectors. This is the same facility that is to be used to manufacture Injectafer for the US market. The company is working with FDA to resolve the issues found in FDA's recent inspection. Luitpold believes it has adequately responded to all the clinical questions concerning Injectafer raised by FDA during the current review period.
Priority review
■ Cabozantinib (Exelixis), a potent dual inhibitor of the MET and VEGF pathways designed to block MET-driven tumor escape, for the treatment of an advanced form of medullary thyroid cancer.
■ Eltrombopag (Promacta, Ligand Pharmaceuticals and GlaxoSmithKline) thrombopoeitin receptor agonist for the treatment of thrombocytopenia in patients with chronic hepatitis C virus infection.
■ AEZS-130 oral ghrelin agonist (Aeterna Zentaris) as a diagnostic test for adult growth hormone deficiency.
Orphan drug designations
■ Inhaled nitric oxide (GeNO LLC) (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of pesistent pulmonary hypertension in newborns.
■ Gevokizumab (XOMA) IL-1 beta modulating antibody for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
First-time generic approvals
Calcipotriene cream (equiv to Dovonex)
SANDOZ
Montelukast sodium (equiv to Singulair) tablets
APOTEX, AUROBINDO PHARMA, ENDO PHARMACEUTICALS, GLENMARK GENERICS, KUDCO IRELAND, MYLAN, ROXANE LABORATORIES, SANDOZ, TEVA, AND TORRENT
Montelukast sodium (equiv to Singulair) chewable tablets
APOTEX, AUROBINDO, ENDO, KUDCO, MYLAN, ROXANE, SANDOZ, TEVA, AND TORRENT
Montelukast sodium (equiv to Singulair) oral granule form
TEVA
Lidocaine topical patch 5% (equiv to Lidoderm)
WATSON
Filgrastim (equiv to Neupogen)
TEVA
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.