Formulary Watch |

Risedronate sodium delayed-release tablets (Atelvia): A once-weekly oral bisphosphonate

New molecular entity: Risedronate sodium delayed-release tablets (Atelvia) were approved for the treatment of postmenopausal osteoporosis

Dabigatran may be a cost-effective alternative to warfarin for stroke prevention in atrial fibrillation

The recently FDA-approved oral direct thrombin inhibitor, dabigatran, may be cost-effective compared to the standard-of-care therapy of adjusted-dose warfarin in patients requiring anticoagulation for stroke prevention in atrial fibrillation, according to a pharmacoeconomic evaluation published in the Annals of Internal Medicine.

FDA faces congressional probes and more transparency and organizational changes

With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of administration health policy and regulatory programs.

FDA Actions in Brief February 2011 (Fortesta, Natroba, Abstral, Acetadote, Viibryd, Intelence)

Recent FDA Approvals (through January 2011) related to Fortesta, Natroba, Abstral, Acetadote, Viibryd, Intelence

Use of HEOR data in formulary decision-making expected to increase

Individuals involved in formulary decision-making processes at US health plans were surveyed to determine their current and future use of health economic and outcomes research.

First-time generic approvals February 2011

Generic drugs approved by FDA (through January 2011): Fentanyl buccal tablets

Contraceptive treatments: A review of current hormone options and newer agents for women

This review discusses current contraceptive options including recently approved, newer agents.

FDA: Dolasetron mesylate IV no longer indicated for CINV

Intravenous dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in adult or pediatric patients due to an associated dose-dependant increase in QTc prolongation, according to a recent FDA drug safety communication.

Study finds different opioids offer variable safety in older adults with noncancer pain

Different opioids had different safety profiles when administered to older adults for noncancer pain, according to results from a new study published in the Archives of Internal Medicine.

Recombinant HPV Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)

New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.

A review of peripherally acting mu-opioid receptor antagonists

This article reviews the emerging class of peripherally acting mu-opioid receptor antagonists and provides insight on formulary considerations when evaluating these agents.

FDA approves vilazodone HCl for MDD

FDA has approved vilazodone HCl tablets (Viibryd, Clinical Data) for the treatment of adults with major depressive disorder.

FDA approves head lice treatment for children and adults

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older.

Formulary design, individual mandate key to healthcare reform law

With the healthcare reform law repeal exercise behind them, Congressional leaders can get down to focusing on ways to eliminate or repair some of the more contentious reform provisions and to modify others, according to policy watchers.

FDA sends complete response letter to MannKind regarding new inhaler

FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.

Merck halts vorapaxar study over bleeding concerns in stroke victims

Concern that its potential clot-preventing drug vorapaxar increased the risk of bleeding in stroke victims has prompted Merck & Co. to halt a late-stage study of the drug, the Associated Press reported.

Medication adherence by elderly after MI is low

Elderly patients have difficulty with long-term adherence to medications following myocardial infarction, and this is significantly worse among those with kidney dysfunction, according to a study published online January 13 in the Clinical Journal of the American Society of Nephrology, HealthDay News reported.

Risk of nontraumatic fractures may rise with use of antiepileptic drugs

Antiepileptic drugs may increase the risk of nontraumatic fractures in patients aged 50 years and older, according to a study published in the January issue of the Archives of Neurology, HealthDay News reported.

Patients see greater BP drop with combination therapy at the start

A combination drug therapy given initially appears to result in better blood pressure control in individuals compared with those who are treated with monotherapy, according to research published online January 13 in The Lancet, HealthDay News reported. Those who underwent the 2-drug treatment after taking the single-drug therapy also experienced better blood pressure outcomes, though not at the same level as those who began with the combination treatment.

NSAID use tied to higher risk of cardiovascular events

Commonly used nonsteroidal anti-inflammatory drugs may increase the risk of heart attack, stroke, and death, according to a meta-analysis published January 11 in British Medical Journal, HealthDay News reported.

Potential confusion in morphine sulfate oral solutions dosage prompts label alteration

FDA and Roxane Laboratories are warning of serious adverse events and deaths as a result of a mistake in dosage of morphine sulfate oral solutions.

Rifaximin could be treatment course for IBS

A 2-week course of rifaximin (Xifaxan, Salix Pharmaceuticals) relieved bloating and other symptoms of irritable bowel syndrome for more than 2 months after treatment ended, according to research published January 6 in the New England Journal of Medicine. Rifaximin is the first treatment that targets the underlying cause of IBS, rather than just treating the symptoms, researchers said.

FDA approves ready-to-use 750-mg dosage of vancomycin

FDA has approved the premix formulation of vancomycin injection, USP (750 mg/150 mL) (Baxter). Vancomycin is an antibiotic used to treat severe infections caused by susceptible strains of methicillin-resistant Staphylococcus aureus and/or treat patients who are penicillin-resistant.

Severe liver injury associated with dronedarone use

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

FDA: Severe liver injury associated with dronedarone use

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

FDA OKs label update for etravirine

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral agents.

Longer oral contraceptive regimens containing a progestogen show higher effectiveness

Twenty-four-day oral contraceptive regimens containing a progestogen with a long half-life shows higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens, according to research published in the January 2011 issue of Obstetrics & Gynecology.

FDA approves Abstral with required REMS enrollment

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gum, tongue), or the nasal passages or throat where they dissolve and are absorbed.

IDSA establishes guidelines to treat MRSA infections

The Infectious Diseases Society of America is set to release its first guidelines for the treatment of the increasingly common and potentially deadly methicillin-resistant Staphylococcus aureus infection.

Generic competition on the horizon as many pharmaceutical companies face patent expirations

The impact of generic drugs-which now account for more than 70% of all prescriptions dispensed in the United States-will continue to increase as some of the world's most-prescribed products lose their patent protection in 2011 and begin facing generic competition.