Formulary Watch |

FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans

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.

Generic inhaled corticosteroids: Current status and what to expect next

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.

Brand-name statin prescriptions account for $5.8 billion in costs

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 at risk for high blood pressure

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 approves bupivacaine hydrochloride injection, USP

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 resubmits NDA for Qnexa

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

FDA approves Ferriprox to treat excess iron

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.

Teriflunomide reduces annual relapse rate in patients with relapsing MS

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 appears ineffective for easing UT symptoms associated with BPH

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.

Promising data revealed for COPD patients

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 more prevalent among youth with diabetes

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.

Study offers bivalirudin dose estimates for patients with varying degrees of renal function

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.

AAP, CDC publish new Tdap vaccine recommendations

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.

FDA: Dasatinib use may increase risk of PAH

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 approves Combivent Respimat Inhalation Spray for patients with COPD

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 approves sitagliptin and simvastatin combination therapy

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 approves tadalafil to treat BPH and ED

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 approves tadalafil to treat benign prostatic hyperplasia

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.

Formulary Digital Edition October 2011

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

Drug companies should report clinical trial results, even when they won't lead to a product

Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research, even when product development is no longer being pursued.

Ticagrelor (Brilinta): An oral P2Y12 platelet inhibitor to reduce rate of thrombotic cardiovascular events in patients with acute coronary syndrome

New molecular entity: Ticagrelor tablets were FDA approved to reduce rate of thrombotic cardiovascular events in patients with ACS.

Dapagliflozin: An emerging treatment option for type 2 diabetes mellitus

Dapagliflozin is a sodium glucose co-transporter inhibitor under review for FDA approval for the treatment of type 2 diabetes mellitus. Despite the availability of many antidiabetic agents in the United States, type 2 diabetes remains inadequately controlled in many patients.

Zoledronic acid (Reclast) prescribing information to list renal dysfunction as contraindication

FDA is requiring the zoledronic acid (Reclast, Novartis) prescribing information to now include a warning not to use the drug in those with renal dysfunction.

Global health challenges spur development of vaccines at home and abroad

It's flu season again, which always focuses public attention on the reliablity and availability of the nation's vaccine supply.

Early antiretroviral therapy reduces HIV-1 transmission risk to uninfected partners in sexually active couples

In sexually active partners, early treatment with antiretroviral therapy compared to delayed treatment decreased the risk of genetically linked HIV-1 transmission to the uninfected partner.

More potent vascular endothelial growth factor targeting improves progression-free survival as second-line treatment in metastatic renal cell carcinoma

Axitinib, an investigational selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 significantly extended progression-free survival compared with sorafenib in patients with previously treated metastatic renal cell carcinoma.

Pentavalent vaccine reduces rotavirus-associated healthcare use and cost in children less than 5 years of age

Diarrhea-associated healthcare utilization and treatment costs for US children <5 years of age

FDA Pipeline Preview, October 2011 (Janssen Biotech, GlaxoSmithKline, Pfizer, Johnson & Johnson, Bayer AG, ApoPharma, BTG, Chelsea Therapeutics, QLT, Neuraltus Pharmaceuticals, Accentia, 4SC, Tarix Pharmaceuticals)

Recent FDA action (through September 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

Rivaroxaban antibiotic (Xarelto): Anticoagulant for the prevention of venous thromboembolic events following total hip and knee replacement surgery

New molecular entity: Rivaroxaban was FDA approved for prevention of deep vein thrombosis.

Labels for TNF-alpha blockers to warn of potential for infection

In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.