Formulary Watch |

ACE inhibitors versus ARBs for ischemic heart disease: comparative effectiveness

A systematic review into the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), or both, for patients with stable ischemic heart disease and preserved left ventricular (LV) function found that adding an ACE inhibitor to standard treatment can improve outcomes.

Pralatrexate injection (Folotyn): Folate analogue metabolic inhibitor approved for treatment of relapsed or refractory peripheral T-cell lymphoma

New molecular entity: Pralatrexate injection (Folotyn) was approved on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

Erectile dysfunction and premature ejaculation: underlying causes and available treatments

This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.

Drug pricing, safety, access to dominate agenda in the year ahead

The new team heading up FDA will be firmly established and eager to implement new policies and programs. Payers, plans, and formulary committees will be watching key trends that will shape drug development and coverage in 2010:

First-time generic approvals, January 2010

Generic drugs approved by FDA (through January 2010): Nizatidine oral solution in the 15 mg/mL strength

Dabigatran compared to warfarin when given to patients with atrial fibrillation

Dabigatran, a new oral direct thrombin inhibitor, given to patients with atrial fibrillation at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.

FDA actions in brief, January 2010 (Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate)

Recent FDA approvals (through January 2010) related to Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate

Statin use lowers risk of gallstones followed by cholecystectomy

Use of statins over a long period of time was associated with a decreased risk of gallstones followed by cholecystectomy.

Some fertility drugs pose slight risk of cancer, based on duration of use

Use of fertility drugs does not seem to generally increase uterine cancer risk, however, a Danish study identified small increases in risk from certain fertility drugs used for a longer period.

No change in FDA approval time despite new technology, study shows

Even given implementation of information technology, FDA drug approval time has not decreased, according to researchers.

IDSA requests 10 new antibiotics by 2020

The Infectious Diseases Society of America (IDSA) is calling for development of 10 new antibiotics by 2020

Formulary Digital Edition December 2009

Fibromyalgia: A review of management options; Focus on eslicarbazepine acetate; Agents in late-stage development for the treatment of orphan diseases

Drug Watch: Agents in late-stage development for the treatment of orphan diseases (December 2009) (PDF)

Agents in late-stage development for the treatment of orphan diseases.

Telmisartan/amlodipine (Twynsta): approved for high blood pressure

New combination: Telmisartan/amlodipine (Twynsta) was approved on October 16, 2009, for high blood pressure.

Eslicarbazepine: A novel antiepileptic agent designed for improved efficacy and safety

Eslicarbazepine acetate (eslicarbazepine, or ESL) is a new antiepileptic agent awaiting FDA approval.

FDA actions in brief, December 2009 (Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, Byetta)

Recent FDA approvals (through December 2009) related to Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, and Byetta.

First-time generic approvals, December 2009

Generic drugs approved by FDA (through December 2009): Lansoprazole 15 mg and 30 mg tablets and Perindopril erbumine tablets, 2 mg, 4 mg, and 8 mg

Telmisartan (Micardis): Angiotensin II receptor blocker tablets approved for cardiovascular risk reduction for patients unable to take an ACE inhibitor

New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.

Generic drugs dominate market, look to expand into biologics

Fibromyalgia: A review of management options

Evidence-based recommendations utilize an integrated approach that combines nonpharmacologic approaches (specifically patient education, exercise, and cognitive behavioral therapy) and pharmacologic approaches in the management of fibromyalgia.

Statins improve H1N1 survival

Hospitalized patients with the seasonal flu who were taking statins were twice as likely to survive than those who weren't taking the drug.

Statins may have negative effect on some cardiac patients

Statins may have negative effects on some cardiac patients, according to a study presented at CHEST 2009.

NSAIDs reduce mortality in colorectal cancer

Prediagnosis regular nonsteroidal anti-inflammatory drug (NSAID) use and prolonged duration of NSAID use were independently associated with decreased overall mortality and colorectal cancer (CRC) mortality in women with a first primary invasive CRC, according to a large cohort study.

Rare strain of S. Aureus is found to be the deadliest

USA600, a rare strain of drug-resistant Staphylococcus aureus is about 5 times more deadly than other strains, according to a study at Henry Ford Hospital in Detroit.

Some antibiotics tied to birth defects

Researchers studying the association between birth defects and antibiotics use early in pregnancy-1 month before through the third month-have found a link between common drugs used to treat urinary infections with birth defects.

FDA initiative announced to reduce preventable harm from medication

FDA announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.

Formulary Digital Edition November 2009

Focus on 2009: A year of novel pharmacologic agents in review; Focus on travoprost; Agents in late-stage development for the treatment of gastrointestinal disorders

Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (November 2009) (PDF)

Agents in late-stage development for the treatment of gastrointestinal disorders

Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis

New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Focus on 2009: A year of novel pharmacologic agents in review

This article reviews the 10 newly improved or investigational agents evaluated in this year's "Focus on" column and includes an update on the regulatory status of each drug.