Roflumilast is a novel, orally active phosphodiesterase 4 inhibitor currently under review by FDA for the treatment of patients with moderate-to-severe COPD.
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Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate
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.
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.
This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.
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:
Generic drugs approved by FDA (through January 2010): Nizatidine oral solution in the 15 mg/mL strength
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.
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
Use of statins over a long period of time was associated with a decreased risk of gallstones followed by cholecystectomy.
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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.
Even given implementation of information technology, FDA drug approval time has not decreased, according to researchers.
The Infectious Diseases Society of America (IDSA) is calling for development of 10 new antibiotics by 2020
Fibromyalgia: A review of management options; Focus on eslicarbazepine acetate; Agents in late-stage development for the treatment of orphan diseases
Agents in late-stage development for the treatment of orphan diseases.
New combination: Telmisartan/amlodipine (Twynsta) was approved on October 16, 2009, for high blood pressure.
Eslicarbazepine acetate (eslicarbazepine, or ESL) is a new antiepileptic agent awaiting FDA approval.
Recent FDA approvals (through December 2009) related to Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, and Byetta.
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
New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.
Generics makers have aggressively challenged drug patents before scheduled expiration, while brand-name manufacturers have delayed generic entry through 30-month stays, citizen petitions, and deals to "authorize" generic products that are less threatening to the brand.
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.
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 effects on some cardiac patients, according to a study presented at CHEST 2009.
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.
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.
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