Generic drugs approved by FDA (through April 2008) including cefuroxime for oral suspension, pramipexole tablets, alendronate once-daily tablets, and alendronate once-weekly tablets.
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Recent FDA approvals and indications (through April 2008) related to Xyntha, Simcor, Aloxl, Humira, Abilify, Avastin, Nexium, and Luvox.
Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.
New biologic: Rilonacept (Arcalyst), a regeneron Interleukin-1 blocker was recently approved for the treatment of cryopyrin-associated periodic syndromes (CAPS).
NME: Desvenlafaxine (Pristiq), a selective serotonin and norepinephrine reuptake inhibitor was recently approved for the treatment of major depressive disorder.
Drugs in development for the treatment of Huntington disease, Parkinson disease, and amyotrophic lateral sclerosis
Bevacizumab plus paclitaxel can slow breast cancer progression but does not improve overall survival
Adding bevacizumab to treatment with paclitaxel does not prolong overall survival among patients with metastatic breast cancer; however, the combination therapy is associated with a significant improvement in progression-free survival, according to the results of a trial published in the New England Journal of Medicine (NEJM).
This article discusses pharmacologic options for the treatment of Crohn's disease, including aminosalicylates, corticosteroids, immunosuppresant agents, and biologic agents.
First-time generic approval: Balsalazide capsules
A summary of drugs and indications recently approved by FDA: Intelence, Alvesco Inhalation Aerosol, Moxatag, Humira, Asmanex, Tekturna HCT, Herceptin
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FDA-related information through March 2008 on C1 inhibitor, ferric carboxymaltose injection, lovastatin, carbidopa/levodopa extended release, vigabatrin, bortezomib, peginterferon alfa-2b, elesclomol, triphendiol, VQD-002
Colesevelam (Welchol) was approved on January 18, 2008, as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
Labeling changes and safety information regarding Botox, selected antiepileptic drugs, Chantix, and Ortho Evra (through March 2008)
Etravirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) that was approved January 18, 2008, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to NNRTIs and other antiretroviral agents.
A review of agents in late-stage development as of March 2008 for the treatment of diabetic retinopathy, dry eye syndrome, macular degeneration, and diabetic macular edema
The use of rosiglitazone to treat type 2 diabetes in older patients has been associated with an increased risk of cardiovascular events.
In 2 studies, lenalidomide plus dexamethasone has been demonstrated to be an effective therapy for relapsed and/or refractory multiple myeloma.
Report by FDA's Science Board cites a need for updates to the agency's information infrastructure and research programs to avoid significant problems.
First-time generic approval: Granisetron injection
A summary of drugs and indications recently approved by FDA: Cialis, Evicel, Voluven, Thyrogen, Diovan, Cymbalta, Triesence, Vyvanse, Glumetza, Sular
Ceftobiprole is the first anti-MRSA cephalosporin antibiotic to be sumbitted to FDA for approval. If approved, the drug will likely be considered a second-line antibiotic for the treatment of cSSSIs.
This article provides information about pharmacologic and nonpharmacologic treatments that are used to help people stop smoking, including the use of varenicline.
FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120
FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120
FDA approved nebivolol on December 17, 2007, as monotherapy or in combination with other antihypertensive agents for the treatment of hypertension.
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