FDA recommends against use of Revatio in children with pulmonary hypertension
August 31st 2012FDA issued a Drug Safety Communication on sildenafil (Revatio, Pfizer), following the observation in a long-term extension of a clinical trial in pediatric patients with pulmonary arterial hypertension of an increase in mortality with increasing Revatio dose.
FDA approves new treatment for severe neutropenia in certain cancer patients
August 30th 2012FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.
FDA approves first drug formulated for children with rare brain tumor
August 29th 2012FDA has approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis), a new pediatric dosage form of the anti-cancer drug everolimus (Afinitor, Novartis) used to treat a rare brain tumor called subependymal giant cell astrocytoma.
FDA approves new combination tablet for HIV treatment in some patients
August 29th 2012FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
FDA approves tapentadol ER for neuropathic pain associated with DPN
August 29th 2012FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Generics saved Americans $1 trillion over 10 years
August 24th 2012The use of generic prescription drugs instead of their brand-name counterparts has saved Americans and the nation's healthcare system $1.07 trillion over 10 years ending in 2011, according to the results of a study commissioned by the Generic Pharmaceutical Association.
FDA approves first generic Actos to treat type 2 diabetes
August 17th 2012FDA 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.
Medication reconciliation important to avoid errors
August 17th 2012It’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.
Metastatic colorectal cancer treatment is approved
August 6th 2012FDA 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.