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).
FDA approved a new indication for denosumab (Prolia, Amgen) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.
FDA notified healthcare professional about a possible increased failure of heart risk with pramipexole (Mirapex).
FDA has granted fast-track designation for the development of AVI-7288 and AVI-7537 (Sarepta Therapeutics), for the treatment of Marburg virus and Ebola virus, respectively.
FDA is warning consumers not to use Intestinomicina (Laboratorios Lopez), a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a healthcare provider.
FDA has approved poly-ureaurethane 16% (Nuvail, Innocutis) nail solution to help manage fragile, damaged or brittle nails with cracking or splitting, a condition medically referred to as "nail dystrophy."
Consumers say that choosing healthcare benefits is the most difficult major life decision behind saving for retirement.
Researchers at Weill Cornell Medical College have discovered that an off-patent anti-inflammatory drug kills both replicating and non-replicating drug resistant tuberculosis in the laboratory.
Since posting its lowest annual growth rate in more than six years, the average cost of healthcare services accelerated in May and June.
The U.S. can learn from ways other countries slow prescription drug spending growth, according to a new policy analysis from the National Institute for Health Care Reform (NIHCR)
The Aetna Innovation Labs were created to test specific initiatives, determine success rates and impact, and expand programs that show promise.
Survey taker says payers are the only winners in healthcare reform; calls ACO member rules silly.
HealthPartners and Park Nicollet Health Services, have decided to combine to create an integrated healthcare delivery and financing powerhouse.
FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.
FDA has approved teriflunomide (Aubagio, Genzyme, a Sanofi company), a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis.
Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary, nationwide retail-level recall for 1 lot of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.
FDA has approved the production and use of Choline C-11 Injection (Mayo Clinic PET Radiochemistry Facility), a PET imaging agent used to help detect recurrent prostate cancer.
Legislation proposed by Michigan's governor would modernize the state's regulatory system in time for changes under PPACA.
Gabapentin may be an effective and well-tolerated treatment for patients with refractory chronic cough, according to a study published August 28 in The Lancet.
A fixed-dose combination of azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) was statistically superior to azilsartan medoxomil coadministered with hydrochlorothiazide at reducing and maintaining systolic blood pressure, according to the results of a phase 3 study published online August 31 in The American Journal of Medicine.
Medicare payments for sleep testing increased by $173 million from 2001 to 2009.
An FDA advisory panel voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (Novartis) for the management of cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.
FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis.
CDC recommends value-based strategies to help members control high blood pressure
The Medicare Part D prescription drug program has emerged as the poster child for how private plans can control costs while providing quality care. Even critics of health insurers acknowledge that the drug benefit has been a success.
Drug Watch: Pain
Recent FDA action (through August 2012) related to, ferric carboxymaltose injection, Injectafer, abiraterone acetate, Zytiga, cabozantinib, Exelixis, eltrombopag, Promacta, AEZS-130 oral ghrelin agonist, inhaled nitric oxide, GeNO LLC, gevokizumab, XOMA, calcipotriene cream, Dovonex, montelukast sodium, Singulair, lidocaine topical patch 5%, Lidoderm, filgrastim, Neupogen
New molecular entity: FDA approved Mirabegron (Myrbetriq, Astellas Pharma US) for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Irritable bowel syndrome is functional gastrointestinal disorder that is expensive to treat and can impair quality of life. Current therapies are reviewed.