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Recent FDA action (through February 2013) related to, rintatolimod, insulin degludec, insulin degludec/insulin aspart, dolutegravir, Radium-223 dichloride, APG101, LG631-CD34, Placental eXpanded, buprenorphine hydrochloride, naloxone HCI dihydrate, doxorubicin hydrochloride, clindamycin in 5% dextrose, Adderall
Complete response
â¾ Rintatolimod (Ampligen, Hemispherx Biopharma) for chronic fatigue syndrome (CFS). FDA said Hemispherx should conduct at least 1 additional clinical trial, complete various nonclinical studies, and perform a number of data analyses. In the complete response letter (CRL), FDA set forth the reasons for this action and provided recommendations to address certain outstanding issues. FDA stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. Hemispherx plans to request an end-of-review conference with FDA as a precursor to submitting a formal appeal to the Office of New Drugs in FDA’s Center for Drug Evaluation and Research regarding the Agency’s decision.
â¾ Insulin degludec (Tresiba, Novo Nordisk) and insulin degludec/insulin aspart (Ryzodeg, Novo Nordisk) for the treatment of diabetes. In the CRL, FDA requested additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013. In the letter, FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced warning letter, dated December 12, 2012, have been resolved.
Priority review
â¾ Dolutegravir (GlaxoSmithKline and ViiV) for the treatment of HIV/AIDS.
â¾ Radium-223 dichloride (radium-223, Bayer HealthCare) for the treatment of castration-resistant prostate cancer patients with bone metastases.
Orphan drug designations
â¾ APG101 (Apocept, Apogenix GmbH), a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG, for the treatment of myelodysplastic syndromes.
â¾ LG631-CD34 (Lentigen) for bone marrow protection in the treatment of glioblastoma multiforme.
â¾ PLacental eXpanded (PLX) cells (Pluristem Therapeutics) for the treatment of aplastic anemia.
â¾ First-time generic approvals
Buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets in 2-mg/0.5-mg and 8-mg/2-mg strengths (equiv to Suboxone) amneal pharmaceuticals
Doxorubicin hydrochloride liposome injection (equiv to Doxil) sun pharma global
Clindamycin in 5% dextrose (equiv to Cleocin Phosphate in Dextrose 5%) sandoz
Mixed salts of a single-entity amphetamine in 5-mg, 15-mg, 20-mg, 25-mg, and 30-mg capsules (equiv to Adderall) 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.
