In the first use of a framework allowing submission of a single application to the two agencies, FDA and EMEA worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs.
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ETHEX Corporation has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness.
Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall.
FDA announced the addition of a boxed warning to the label of Regranex Gel 0.01% to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product.
Americans noted that their highest health care priority is reducing the cost of prescription drugs.
SteriFx recently confirmed that poultry processing plants using FreshFx to acidify the scalder water have demonstrated a reduction in pathogen load.
Ultra-high doses of resveratrol, equivalent to 1500 bottles of wine or many dietary supplement capsules, successfully overcame the adverse effects of a high-fat diet, the lowest dose that genetically mimics a calorie restricted diet went undetermined, till now.
Watson Pharmaceuticals has received approval from FDA for Potassium-Chloride Extended-Release Capsules USP in the 8mEq and 10mEq strengths.
Wyeth Pharmaceuticals announced that FDA has issued an approvable letter for the first-in-class antibiotic TYGACIL for the treatment of adult patients with community-acquired pneumonia (CAP).
Lupin Pharmaceuticals has received tentative approval for ANDA for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from USFDA.
The technical standards necessary to establish a national electronic prescribing system already have been adopted by physicians and pharmacy software companies.
Sucampo Pharmaceuticals and Takeda Pharmaceuticals announced that AMITIZA 8 mcg capsules are now available by prescription in pharmacies across US for the treatment of Irritable Bowel Syndrome.
Food and Drug Administration (FDA) and Medicare will cooperate on launching a new program, which will help in monitoring safety problems of drugs and medical devices that are already in the U.S. prescription drug market.
The manufacturer prices for 185 generic medications decreased by an average of 9.6% in 2007.
FDA recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than two.
Food 4 Less in-store pharmacies will expand its generic drug program - offering customers lower prices and additional drug choices to meet their health needs.
Diabetes treatments are now the leading driver of prescription drug spending growth, displacing lipid-lowering drugs which fell precipitously after a decade of reigning in the top position, as generic drugs cut the cost of treating high cholesterol. These new findings were reported by Medco Health Solutions Inc., the nation's leading pharmacy benefit manager, in its just-released 2008 Drug Trend Report, a comprehensive analysis of prescription drug spending and utilization.
FDA has granted orphan drug designation to Ergonex Pharma's Terguride for the treatment of pulmonary arterial hypertension.
Bayer HealthCare Pharmaceuticals has notified the FDA that the company will begin removing the remaining Trasylol stock from US market, most of which is in warehouses and hospital or physician's stock.
Simcere Pharmaceutical Group has received approval from SFDA to manufacture and market a first- to-market generic Biapenem injection under the brand name Anxin.
Mylan Pharmaceuticals has launched Paroxetine Hydrochloride Extended-release Tablets, the generic version of GlaxoSmithKline's Paxil CR.
New soluble polymer material designed to stop bone bleeding in surgery improves bone fusion and healing.
People with leg cramps caused by narrowing blood vessels often stop walking because of the pain. In fact, some say they have "shop window disease," because they pretend to gaze into store windows during the embarrassing pauses. But those who take naftidrofuryl -- a drug that relaxes blood vessels -- don't have to pause nearly as often, according to a new review by Belgian researchers.
A coalition of Massachusetts community organizations, nonprofits, insurers, and health care providers is asking the state government to regulate the marketing practices of pharmaceutical companies, claiming it will help ensure more affordable prescription drugs for everyone.