After reviewing new data, FDA has concluded that Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg.
FDA has approved Boston Therapeutic’s petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of the diabetes drug metformin hydrochloride. The company plans to market the new formulation under the name Pazamet.
Tranexamic acid can safely be used in all trauma patients, not just those who are the most severely injured, according to data analyses results published in the September 11 issue of the British Medical Journal.
Treatment with omega-3 polyunsaturated fatty acides to prevent cardiovascular disease (CVD) has been controversial. A recent meta-analysis and review showed that overall, omega-3 PUFA supplementation did not lower the risk of CVD, according to data published in the Sept. 12, 2012 issues of JAMA.
Long-term use of nonsteroidal anti-inflammatory drugs following a first-time myocardial infarction is associated with persistent increased cardiovascular risk, according to an online study published September 24 in the journal Circulation.
FDA has granted delafloxacin (Rib-X) as a Qualified Infectious Disease Product (QIDP) for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Apixaban (Eliquis), an investigational anticoagulant developed by Bristol-Myers Squibb and Pfizer, has lower rates of stroke, systemic embolism, and bleeding than warfarin in patients with atrial fibrillation, regardless of level of risk for these events, according a recent online analysis published October 2 in The Lancet.
Paliperidone palmitate (Invega Sustenna), a monthly extended-release injectable suspension atypical antipsychotic for the treatment of schizophrenia, has a new updated product label that describes greater flexibility and dosing options for healthcare providers as well as additional warnings and precautions, according to its manufacturer, Janssen Pharmaceuticals.
A recent study indicates that hospitals can reduce readmission rates if they work on medication reconciliation.
In the quest to adopt personalized medicine approaches, optimizing antiplatelet therapy based on platelet function testing is controversial.
Tofacitinib is a novel JAK inhibitor, selective for JAK 1 and JAK 3.
Recent FDA action (through September 2012) related to, Lymphoseek, technetium Tc 99m tilmanocept, Tobramycin inhalation powder, Lixivaptan, CRTX 080, ALV003, AB103, Atox Bio
Recent FDA Approvals (through August 2012) related to (Innocutise, Genzyme, Sanofi, Pfizer, Amgen, Astellas Pharma US, Medivation, Gilead Sciences, Ironwood Pharmaceuticals, Forest, Reckitt Benckiser, Boehringer Ingelheim, Eli Lilly, Sicor Biotech UAB, Teva Corporation, Novartis)
New molecular entity: FDA approved the combination of sodium picosulfate (a stimulant laxative) and magnesium oxide and anhydrous citric acid (which form magnesium citrate, an osmotic laxative) (Prepopik, Ferring Pharmaceuticals) for cleansing of the colon as a preparation for colonoscopy in adults.
Rheumatoid arthritis is an autoimmune disorder in which the immune system targets synovial joints and causes mild-to-severe joint disease with extra-articular manifestations. This review discusses the current standards of care and details the data being collected on new agents.
Incretin-based therapies are now the most promising therapies for type 2 diabetes.
Janssen Pharmaceuticals, Inc. is making it easier for pharmacists and healthcare professionals to look up drug information by launching an online scientific resource tool.
FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.
FDA approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy).
The long-term use of gingko biloba extract does not lower the risk of Alzheimer’s disease, according to a report published September 6 online for The Lancet.
Tight glycemic control can be achieved in children following cardiac surgery, but it does not reduce the infection rate, mortality, or length of hospital stay compared to standard care, according to a study published in the September 7 issue of The New England Journal of Medicine
An Endocrine Society task force has established new clinical-practice guidelines that recommend screening adults for high triglyceride levels once every 5 years because of the potential risk of cardiovascular disease and pancreatitis associated with hypertriglyceridemia.
FDA is supporting antibacterial drug development by launching a new internal task force, according to a press release today.
FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).
