Formulary Watch |

Milnacipran (Savella): Selective norepinephrine and serotonin reuptake inhibitor approved for the management of fibromyalgia

New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia

FDA seeks more resources and new leadership

For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.

FDA guidance on reprint practices: Dissemination of off-label information OK

In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.

FDA: Ezetimibe/simvastatin (Vytorin) effective in lowering LDL

After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.

Antidepressants associated with improvements in fibromyalgia symptoms

A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).

Telepharmacy reaches out to the underserved

Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.

In the pipeline: Drugs to watch in 2009

Several blockbuster drugs will fight to hold onto their top spots in 2009 as new products come before FDA for marketing approval, reported Brian W. Kolling, PharmD, at a recent meeting of the Academy of Managed Care Pharmacy (AMCP) in Kansas City, Mo. Key therapies to watch as they move through the pipeline include medications for cardiovascular (CV) disorders, central nervous system (CNS) disorders, respiratory disease, and diabetes.

Formulary Digital Edition January 2009

Outpatient pharmacologic management of ACS using antiplatelet therapy; Focus on sugammadex; Drug Watch: Agents in late-stage development for the treatment of depression and generalized anxiety disorder

Eltrombopag (Promacta): Thrombopoietin (TPO) receptor agonist approved for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP)

New molecular entity: Eltrombopag (Promacta), a TPO receptor agonist, was approved on November 20, 2008, for the treatment of thrombocytopenia in patients with chronic ITP.

FDA Pipeline preview, January 2009 (ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, ecallantide)

Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide

First-time generic drug approvals, January 2009

Generic drugs approved by FDA (through January 2009) including rocuronium injection and budesonide inhalation suspension

FDA actions in brief, January 2009 (Banzel, tapentadol, synthetic conjugated estrogens-A, Ranexa)

Recent FDA approvals (through January 2009) related to Banzel, tapentadol, synthetic conjugated estrogens-A, and Ranexa

Outpatient pharmacologic management of ACS using antiplatelet therapy: A review of recent guidelines and agents in the pipeline

Acute coronary syndrome (ACS) encompasses a series of heart conditions associated with myocardial ischemia.

Sugammadex: A selective relaxant binding agent for neuromuscular block reversal

Sugammadex is a novel, first-in-class, selective relaxant binding agent that encapsulates the nondepolarizing aminosteroid muscle relaxants rocuronium and vecuronium, reversing and preventing their neuromuscular block (NMB) action. Clinical trials have demonstrated that sugammadex is effective in reversing both rocuronium- and vecuronium-induced NMB, and the agent has been well tolerated in studies.

Drug Watch: Agents in late-stage development for the treatment of depression and generalized anxiety disorder (January 2009) (PDF)

Agents in late-stage development for the treatment of depression and generalized anxiety disorder

IMS v Ayotte: NH's Prescription Information Law is constitutional

The Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire's Prescription Information Law "that among other things prohibited certain transfer of physicians' prescribing histories for use in detailing" regulates conduct, not speech, thereby removing "the challenged portions of the statute from the proscriptions of the First Amendment."

Tinzaparin increases mortality risk in elderly patients

FDA announced that the agency is evaluating data from a clinical study in which all-cause mortality was increased among patients treated with tinzaparin (Innohep, Celgene) versus patients treated with unfractionated heparin (UFH).

Phenytoin, fosphenytoin associated with serious skin reactions in patient subset

FDA informed healthcare professionals that the agency is evaluating data regarding a potentially increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, in association with phenytoin (Dilantin, Pfizer; Phenytek, Mylan; generic phenytoin) or fosphenytoin (Cerebyx, Pfizer; generic fosphenytoin) treatment in Asian patients who are positive for the human leukocyte antigen allele HLA-B*1502.

Rosiglitazone associated with higher mortality rate versus pioglitazone

Rosiglitazone was associated with an increased risk of all-cause mortality and congestive heart failure (CHF) compared with pioglitazone in an inception cohort study of patients aged >65 years. Patients treated with rosiglitazone or pioglitazone demonstrated similar rates of myocardial infarction (MI) and stroke. These results were published in the Archives of Internal Medicine.

Peginterferon maintenance therapy does not improve progression in HCV

Patients with chronic hepatitis C virus (HCV) infection who have not responded to previous treatment with pegylated interferon alfa-2a (peginterferon) and ribavirin do not demonstrate a reduced rate of disease progression when they undergo long-term treatment with pegylated interferon alfa-2a compared with untreated patients. These results were published in the New England Journal of Medicine.

Generic CV drugs are clinically equivalent to brand-name drugs

Evidence supports the clinical equivalence of generic and brand-name cardiovascular drugs, according to a meta-analysis published in the Journal of the American Medical Association. Despite this evidence, more than half of the editorials discussing the issue of generic interchangeability that were assessed in this analysis do not support generic substitution for brand-name cardiovascular drugs.

Formulary Digital Edition December 2008

Clinical news updates from the 2008 American Heart Association Scientific Sessions; Preferential formulary listing of a proton-pump inhibitor; Drug Watch: Agents in late-stage development for the treatment of multiple sclerosis

Toviaz (fesoterodine): Muscarinic receptor antagonist approved for the treatment of overactive bladder

New molecular entity: Fesoterodine (Toviaz), a muscarinic receptor antagonist, was approved on October 31, 2008, for the treatment of overactive bladder

Second-generation antidepressants similar in efficacy

Second-generation antidepressants generally have equivalent efficacy, according to a review published in the Annals of Internal Medicine. Although these agents demonstrate similar response rates, differences in onset of action or side effects may affect prescribing decisions.

Labeling updates and warnings through December 2008 for efalizumab and bisphosphonates

Labeling updates and warnings through December 2008 for efalizumab and bisphosphonates

Bevacizumab associated with increased risk of venous thromboembolism

Treatment with bevacizumab is associated with a significantly increased risk of venous thromboembolism, according to a meta-analysis published in the Journal of the American Medical Association.

Economic crisis will challenge Obama's health coverage expansion plans

2008 American Heart Association Scientific Sessions: Clinical news updates

Among the new data presented at the 2008 AHA Scientific Sessions were the results of JUPITER, as well as a phase 2 study of rivaroxaban and an observational study of DES versus BMS in diabetics.

FDA Pipeline preview, December 2008 (denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, RTA 402)

Recent FDA action (through December 2008) related to denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, and RTA 402

First-time generic drug approvals, December 2008

Generic drugs approved by FDA (through December 2008) including levetiracetam tablets, dorzolamide/timolol ophthalmic solution, and dorzolamide ophthalmic solution