Formulary Watch |

FDA approves new combination tablet for HIV treatment in some patients

FDA 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

FDA 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.

Long-term PPI use may not influence fracture risk

Long-term use of proton pump inhibitors (PPI) may not significantly influence the development of osteoporosis, according to a recent study published July 10 in The American Journal of Gastroenterology.

Study: Starting dose may be risk factor for AHS

Higher starting doses of allopurinol to treat gout may increase the risk for allopurinol hypersensitivity syndrome, according to a study published in the August 2012 issue of Arthritis & Rheumatism.

Generics saved Americans $1 trillion over 10 years

The 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.

Legislation to create national diabetes commission

A National Diabetes Care Commission will be established if new legislation introduced in the US Senate is passed.

FDA approves first generic version of Lidoderm

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.

FDA approves 2 new dosage strengths of Suboxone

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 approves first generic Actos to treat type 2 diabetes

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 holds experimental HCV drug

FDA has placed a partial clinical hold on Idenix Pharmaceuticals' nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus.

Petition aims to change opioid prescribing

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.

Medication reconciliation important to avoid errors

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 approves prescription fish oil formulation

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.

Early ART for HIV is advised

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 warns of possible fatalities from codeine use in some children after surgical procedures

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 approves vaccine formulation for 2012-2013 influenza season

FDA has approved the influenza vaccine formulation for 6 manufacturers for the 2012-2013 flu season.

OxyContin users are switching to heroin

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.

New therapy for patients with heavy menstrual bleeding

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.

HRT relatively safe for healthy postmenopausal women

Short-term hormone replacement therapy is a relatively safe treatment for healthy, recently postmenopausal women, according to a new consensus statement.

Study: Exposure to H1N1 vaccine during pregnancy did not drive up rate of birth defects

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 grants accelerated approval for treatment of rare type of leukemia

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

FDA clears smart pills that monitor medication adherence

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 approves first generic version of Dovonex cream

FDA has approved Sandoz's calcipotriene cream, the first generic version of Dovonex Cream, 0.005% (Leo Pharma), for the treatment of plaque psoriasis.

Metastatic colorectal cancer treatment is approved

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 approves first generic versions of Singulair to treat asthma, allergies

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.

Study: Intermittent iron supplementation is adequate for anemia prevention

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 rolls out new safety measures for ER, long-acting opioids

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.

Omega-6 fatty acids may help prevent coronary heart disease

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.

Data demonstrate "weekend effect" for AF patients

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.

FDA user fee legislation speeds drug approvals, addresses shortages, counterfeits