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All News - Page 176
Prasugrel unanimously recommended for approval
February 4, 2009
On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).
Formulary Digital Edition February 2009
February 2, 2009
Review of ARV agents for the treatment of HIV infection; Focus on dronedarone; Drug Watch: Agents in late-stage development for the treatment of HIV and AIDS
Drug Watch: Agents in late-stage development for the treatment of HIV and AIDS (February 2009) (PDF)
February 1, 2009
Agents in late-stage development for the treatment of HIV and AIDS
FDA Pipeline preview, February 2009 (asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, vigabatrin)
February 1, 2009
Recent FDA action (through February 2009) related to asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, and vigabatrin
Preventable medication errors: Look-alike/sound-alike mix-ups
February 1, 2009
Confusing drug names, or "look-alike/sound-alike names" (LASAs), are among the most common reasons for medication errors worldwide; these errors can lead to both morbidity and mortality. Both technological innovations and better communication can help healthcare professionals track and prevent these medication mix-ups.
Healthcare reform requires a hard look at drug costs and savings
February 1, 2009
Among members of the new administration, congressional leaders, payors, and providers, many are eager to transform the nation's healthcare system to curb unnecessary spending and make coverage more fair and efficient. A chief problem is that the US healthcare bill keeps increasing faster than the rest of the economy, with little to show in the way of quality improvement.
Dronedarone: An antiarrhythmic agent for the management of atrial fibrillation and atrial flutter
February 1, 2009
Dronedarone, an investigational antiarrhythmic agent being studied for the management of AF and atrial flutter, has a pharmacologic mechanism of action that is similar to that of amiodarone, but dronedarone lacks an iodine moiety, which may result in less thyroid and pulmonary toxicity. Dronedarone is currently pending FDA approval; the agent was granted priority review in August 2008.
Review of antiretroviral agents for the treatment of HIV infection
February 1, 2009
The challenge of controlling HIV in patients with resistance to antiretrovirals has contributed to accelerated research into treatments with novel antiretroviral activity.
FDA actions in brief, February 2009 (Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, AllerNaze)
February 1, 2009
Recent FDA approvals (through Feburary 2009) related to Vasovist, Lusedra, Zingo, Latisse, Gleevec, Nexterone, Zolpimist, Trilipix, Ryzolt, Epiduo, and AllerNaze
Plerixafor (Mozobil): Hematopoietic stem cell mobilizer approved for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM
February 1, 2009
New molecular entity: Plerixafor (Mozobil), a hematopoietic stem cell mobilizer, was approved on December 15, 2008, for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM
Degarelix: GnRH receptor antagonist approved for the treatment of advanced prostate cancer
February 1, 2009
New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer
Milnacipran (Savella): Selective norepinephrine and serotonin reuptake inhibitor approved for the management of fibromyalgia
February 1, 2009
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
January 20, 2009
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
January 20, 2009
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
January 20, 2009
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
January 20, 2009
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
January 20, 2009
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
January 20, 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
January 1, 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)
January 1, 2009
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)
January 1, 2009
Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide
First-time generic drug approvals, January 2009
January 1, 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)
January 1, 2009
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
January 1, 2009
Acute coronary syndrome (ACS) encompasses a series of heart conditions associated with myocardial ischemia.
Sugammadex: A selective relaxant binding agent for neuromuscular block reversal
January 1, 2009
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)
January 1, 2009
Agents in late-stage development for the treatment of depression and generalized anxiety disorder
IMS v Ayotte: NH's Prescription Information Law is constitutional
December 15, 2008
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
December 15, 2008
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
December 15, 2008
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
December 15, 2008
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.
