Formulary Watch |

FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep

FDA approved zolpidem tartrate sublingual tablets (Intermezzo, Transcept Pharmaceuticals) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

FDA changes label for Trilipix

FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.

NHLBI panel recommends universal pediatric screening for cholesterol

All children and adolescents should be screened for high cholesterol, and children as young as aged 10 should be considered for treatment with statins, according to the latest update from an expert panel convened by the National Heart, Lung, and Blood Institute.

AHA, ACC release updated guidelines on secondary prevention of atherosclerotic vascular disease

The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease.

Cancer drugs are in short supply in United States

Some essential chemotherapy drugs are in short supply for the first time in the United States, according to the October 3 New England Journal of Medicine.

FDA mandates enhanced safety check on TNF blockers

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance, the agency said on November 3 in an ongoing safety review of this class of biologic products.

FDA approves aflibercept for patients with wet AMD

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

FDA approves first drug to treat a rare bone marrow disease

FDA approved ruxolitinib (Jakafi, Incyte) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

FDA revokes breast cancer indication for Avastin

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

Formulary Digital Edition November 2011

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Drug Watch: Epilepsy and Parkinson’s disease

Epilepsy and Parkinson’s disease

Tapentadol (Nucynta ER): A mu-opioid receptor agonist for the management of moderate-to-severe chronic pain

New formulation: Tapentadol extended release tablets were FDA approved for the management of moderate-to-severe chronic persistence pain requiring continuous maintenance in adults.

Anticoagulation prophylaxis practice patterns in patients having total hip, total knee replacement in a US health plan

This study aims to illuminate anticoagulation prophylaxis practice patterns in the United States after total joint replacement surgery.

FDA requires several changes to bevacizumab label to include safety information

Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.

Drug shortages challenge the healthcare community, FDA, and pharmaceutical manufacturers

The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House, Congress and the broader healthcare system.

Switching patients from IV to oral form of drugs could save millions, reduce adverse events

Switching hospitalized patients able to take medication by mouth from intravenous to pill forms of the same drugs could safely save millions of dollars a year.

Decision-makers urged to put personalized medicine into action

Pharmacogenomics can change the way patients are treated.

Better medication adherence leads to better outcomes in hepatitis C

Patients with hepatitis C virus (HCV) who were more adherence to their pegylated interferon and ribavirin treatment were more likely to achieve both an early and sustained virologic response.

Removing anthracyclines from HER2-positive breast cancer treatment reduces cardiac toxicity

When an anthracycline is not used concomitantly with adjuvant trastuzumab to treat HER2-positive breast cancer, cardiac toxicity is reduced.

Specialty drug category grows with new approvals

Specialty pharmaceutical research and development spending is expected to increase with the focus on "biobetters", biosimilars, and novel therapies.

Creative contracting initiatives key for pharma as competition in RA market increases

The rheumatoid arthritis payer market has experienced increasingly competitive forces, prompting RA drug manufacturers to experiment with new contracting initiatives to gain preferred formulary placement.

FDA Actions in Brief November 2011 (Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox)

Recent FDA Approvals (through October 2011) related to Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox

Ezogabine (Potiga): Oral potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older

New molecular entity: Ezogabine was FDA approved for use as an add-on medication to treat partial-onset seizures associated with epilepsy in adults.

Rosato appointed new AMCP CEO

Edith Rosato, RPh, has recently been appointed new CEO of the Academy of Managed Care Pharmacy.

FDA Pipeline Preview, November 2011 (NuPathe, Teva, Wilex, Atox Bio, Biovest, Dr. Reddy's Laboratories, Apotex, Par Pharmaceuticals)

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

Crizotinib: A novel, targeted gene therapy for the treatment of non-small-cell lung cancer

Crizotinib is a new kinase inhibitor recently approved by FDA for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who express the anaplastic lymphoma kinase gene.

Biosimilars and the Patient Protection and Affordable Care Act: Where do we stand?

Among the long-awaited provisions in PPACA are the additions to the Public Health Service Act that allow for the introduction of biosimilar medications to the marketplace.

FDA warns methylene blue, linezolid may cause serotonin syndrome when co-administered with certain psychiatric medications

Two Drug Safety Communications providing updated warnings regarding potentially serious interactions when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications were released by FDA on October 20, 2011.

FDA approves expanded use of exenatide injection

FDA has approved exenatide (Byetta, Amylin and Eli Lilly) injection as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione, in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

Children’s research discovery aids in adult cancer drug development

The recent approval by FDA of an adult cancer therapy is 1 example of how children’s cancer research benefits patients of all ages.