FDA has approved Watson’s lidocaine topical patch 5%, the first generic version of Lidoderm (Endo) for the relief of pain associated with post-herpetic neuralgia.
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FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.
FDA approved Mylan Pharmaceutical's 15-mg, 30-mg, and 45-mg pioglitazone hydrochloride tablets, the first generic version of Actos (Takeda), along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
FDA has placed a partial clinical hold on Idenix Pharmaceuticals' nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus.
A coalition of 37 doctors, researchers, and public health officials petitioned FDA on July 25 to tighten label restrictions for opioid analgesics in an effort to curb prescription drug abuse.
It’s important to put processes in place to be sure a patient’s medication list at discharge from the hospital is the same information that is provided to the primary care physician to avoid medication errors, a recent study reports.
FDA has approved a prescription fish oil formulation for the treatment of very high levels of triglycerides, according to Amarin, the New Jersey-based biopharmaceutical company that developed the product.
Antiretroviral therapy should be offered to all patients as soon as possible, regardless of CD4 cell count, according to new recommendations offered during the AIDS 2012: XIX International AIDS Conference.
FDA has issued a Drug Safety Communication concerning three children who died and one child who experienced a nonfatal but life-threatening case of respiratory depression after taking the pain-reliever codeine following tonsillectomy and/or adenoidectomy.
FDA has approved the influenza vaccine formulation for 6 manufacturers for the 2012-2013 flu season.
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A new formulation of the widely prescribed painkiller OxyContin has led drug abusers to shift to heroin, according to research results reported as a letter to the editor in the July 12 issue of the New England Journal of Medicine.
An oral dose of modified-release tranexamic acid may offer an effective first-line therapy for patients with heavy menstrual bleeding, according to a recent study published online July 17 in The Annals of Pharmacotherapy.
Short-term hormone replacement therapy is a relatively safe treatment for healthy, recently postmenopausal women, according to a new consensus statement.
A recent Danish study found that exposure to the influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects or preterm births.
FDA has approved vincristine sulfate liposome injection for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) who have had at least 2 relapses or whose disease has progressed following 2 or more anti-leukemia therapies
An ingestible sensor, formally referred to as the Ingestion Event Marker or IEM by Proteus Digital Health, that can report medication adherence and vital signs to physicians has been given the green light by FDA.
FDA has approved Sandoz's calcipotriene cream, the first generic version of Dovonex Cream, 0.005% (Leo Pharma), for the treatment of plaque psoriasis.
FDA has approved ziv-aflibercept (Zaltrap, Sanofi and Regeneron Pharmaceuticals) injection for intravenous infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
FDA approved the first generic versions of montelukast sodium (Singulair, Merck) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
Iron supplementation 2 to 3 times a week may prevent anemia in pregnant women as well as daily supplementation, according to a recent Cochrane systematic review published online July 11.
FDA approved a new REMS for extended-release and long-acting opioids, which is expected to affect more than 20 companies that manufacture opioid analgesics.
A new study has found that omega-6 poly-unsaturated fatty acids can help prevent coronary heart disease (CHD) and that dietary saturated fat increases the risk for CHD.
Patients with atrial fibrillation who are admitted on the weekend are less likely to receive cardioversion procedures and more likely to die than those who are admitted during the week, according to a new study published in the July 15 issue of The American Journal of Cardiology.
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
New molecular entity: FDA approved taliglucerase alfa (Elelyso, Pfizer), a recombinant active form of the glucocerebrosidase enzyme for long-term enzyme replacement therapy (ERT) for adults with type 1 Gaucher disease.
New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
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