Recent FDA action (through October 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001,cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127
Complete response
■ Transdermal sumatriptan migraine patch (Zelrix, NuPathe) for the treatment of migraine. The rejection was based on FDA's belief that the company provided insufficient data to support a migraine indication. The concerns are believed to be related to the safety of the single-use patch, based on questions FDA had regarding sumatriptan's chemical make-up and manufacturing. NuPathe stated in a press release that it will soon be able to provide the FDA with the additional information it is requesting, and may conduct additional studies as well.
Not recommended for approval
Fast-track designation
■ Rencarex (Wilex) for the adjuvant treatment of patients with non-metastatic clear cell renal cell carcinoma.
Orphan drug designations
■ AB103 (Atox Bio) for the treatment of necrotizing soft-tissue infections.
■ Personalized cancer vaccine (Biovest) for the treatment of Waldenstrom's macroglobulinemia.
■ First-time generic approvals
Olanzapine tablets and olanzapine orally disintegrating tablets (equiv to Zyprexa and Zyprexa Zydus, respectively)
DR. REDDY'S LABORATORIES AND TEVA (OLANZAPINE TABLETS); APOTEX, DR. REDDY'S LABORATORIES, AND PAR PHARMACEUTICALS (OLANZAPINE ORALLY DISINTEGRATING TABLETS)
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.