Formulary Watch

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.

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

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

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

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 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.

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.

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 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.

FDA Commissioner Margaret A. Hamburg, MD, recently released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.

Tracking and preparing for the approval of generic products is 1 of the key components of proactive formulary management. Unfortunately, forecasting FDA approval of the first generic inhaled corticosteroid products is difficult.

According to a recent study, $5.8 billion was spent in 1 year on the unnecessary prescription of brand-name statins.

Middle-aged women with RLS may be at higher risk of developing high blood pressure, according to a study published online October 10 in Hypertension: Journal of the American Heart Association.

FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

Vivus has resubmitted its New Drug Application (NDA) for Qnexa (phentermine/topiramate) to FDA.

FDA has approved deferiprone (Ferriprox, ApoPharma) to treat patients with iron overload resulting from blood transfusions in patients with thalassemia who had an inadequate response to previous chelation therapy.

In patients with relapsing forms of MS, once-daily oral teriflunomide 14 mg significantly reduced the annual relapse rate and disability progressions, and improved several MRI measures of disease activity, according to a study recently published in The New England Journal of Medicine.

Saw palmetto fruit extract has no effect on lower urinary tract (UT) symptoms attributed to BPH, regardless of dose, a study published in The Journal of the American Medical Association finds.

Novartis has filed for marketing authorization with the European Medicines Agency of its investigational drug, NVA237 (glycopyrronium bromide), the drug company announced at the European Respiratory Society in Amsterdam, The Netherlands.

Asthma may contribute to poor glycemic control in youth with diabetes, especially if the disease is left untreated, according to the results of a study published online September 26 in Pediatrics.

There is a strong relationship between bivalirudin dosing requirements and renal function when steady state conditions are maintained, results of a study published in the September issue of Pharmacotherapy demonstrate.

The AAP and the CDC have have amended and expanded their recommendations for the use of Tdap, according to a policy statement published online September 26 in Pediatrics.

An FDA Drug Safety Communication sent to healthcare professionals states that Dasatinib (Sprycel, Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension.

FDA has approved ipratropium bromide and albuterol (Combivent Respimat Inhalation Spray, Boehringer Ingelheim), for COPD patients using a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

FDA has approved sitagliptin and simvastatin (Juvisync, MSD International GmbH Clonmel), a fixed-dose combination prescription medication that contains 2 previously approved medications in 1 tablet for use by adults who need both sitagliptin and simvastatin.

FDA has approved tadalafil (Cialis, Eli Lilly) for 3 indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.

FDA has approved tadalafil (Cialis, Eli Lilly) for 3 indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.

Osteoporosis: A review of current recommendations and emerging treatment options; Focus On Dapagliflozin: An emerging treatment option for type 2 diabetes mellitus