Formulary Watch |

New treatment for advanced melanoma approved by FDA

Accelerated approval has been granted by FDA to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients who have unresectable or metastatic melanoma not responding to treatment with other drugs.

Proposed rule from FDA requires electronic prescription drug labeling

According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.

FDA approves first IV flu medication

FDA approved the first intravenous influenza treatment, peramivir (Rapivab, BioCryst).

Some anti-inflammatory drugs may help reduce skin cancer risk

Some anti-inflammatory drugs, including ibuprofen have the potential to prevent the second most common type of skin cancer, according to a study published in the Journal of Investigative Dermatology.

Despite risks in elderly, benzodiazepine use increases with age

Despite known risks of confusion and falls associated with benzodiazepine use in elderly patients, a study published in JAMA Psychiatry, finds that prescription of benzodiazepines increases as people age. The research offers the first estimates of use patterns in the United States.

Link between Rx drugs and teen drug abuse: Study

One medical center is urging parents to seek non-medical solutions for their children’s anxiety or insomnia, after a recent study found that teens prescribed anti-anxiety or sleep medications are up to 12 times more likely to abuse prescription drugs than those who had never been prescribed them.

Class action suit latest problem with Sovaldi

The Southeastern Pennsylvania Transportation Authority (SEPTA) recently filed a class action suit in federal court against Gilead Sciences, Inc. over the high cost of its hepatitis C drug, Sovaldi.

FDA green lights combination antibiotic

FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.

Xtoro approved for swimmer's ear

FDA has approved finafloxacin (Xtoro, Alcon) otic suspension for the treatment of otitis externa.

Lynparza approved to treat advanced ovarian cancer

FDA has approved olaparib (Lynparza, AstraZeneca) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as determined by an FDA-approved test.

FDA allows marketing of first newborn screening test to help detect Severe Combined Immunodeficiency

FDA has allowed marketing of the EnLite Neonatal TREC kit (PerkinElmer), the first newborn screening test for detection of Severe Combined Immunodeficiency (SCID).

FDA approves Viekira Pak to treat hepatitis C

FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

FDA approves first therapy for treating patients with GEP-NETs

FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

FDA grants Lucentis breakthrough therapy for diabetic retinopathy

The FDA has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech) for the treatment of diabetic retinopathy.

Novel new drugs approved in 2014

FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).

New screening test predicts risk of future coronary heart disease

FDA has cleared a new screening test for the prediction of future coronary heart disease (CHD) events, such as myocardial infarction. It is cleared for use in all adults who have no history of CHD.

FDA grants first-ever CLIA waiver of rapid syphilis test

FDA has granted the first-ever CLIA waiver for the Syphilis Health Check test, a rapid screening test for syphilis.

Common osteoporosis drugs may prevent breast, lung, colon cancers

Bisphosphonates, the most commonly used drugs for osteoporosis may be able to reduce the growth of certain cancers by inhibiting the activity of a cancer-producing family of receptor called the human epidermal growth factor receptor (HER), according to 2 studies published online this week in the Proceedings of the National Academy of Sciences (PNAS).

Naloxone price increases may threaten public safety

A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses.

Eli Lilly's Cyramza approved for lung cancer

FDA has approved Cyramza (ramucirumab, Eli Lilly) in combination with docetaxel to treat aggressive non-small cell lung cancer.

New vaccine version approved for cancers caused by additional HPV types

A new vaccine, human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9, Merck Sharp & Dohme), has been approved by FDA for the prevention of diseases caused by 9 HPV types. It is effective against 5 additional strains of the virus than is the previous FDA-approved version of the vaccine (Gardasil).

ASH: Data released on largest clinical trial of myelofibrosis patients treated with ruxolitinib

Data from the largest clinical trial of myelofibrosis patients treated with ruxolitinib (Jakavi, Novartis) support its safety profile and efficacy benefit, as measured in primary and secondary end points, according to a study presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.

First FDA-licensed test approved for confirming human T-cell lymphotropic virus I/II

MP Diagnostics HTLV Blot 2.4 (MP Biomedicals) has been approved by FDA as the first FDA-licensed supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II). It is a qualitative enzyme immunoassay test, which is to be used to confirm the presence of HTLV antibodies as well as to differentiate between HTLV-I and HTLV-II infection.

Clinical study to research use of erectile dysfunction drug to treat vascular dementia

On the 1-year anniversary of the first G8 summit on dementia, new funding has been announced for a study to research the use of tadalafil (Adcirca, Cialis; Eli Lilly), an erectile dysfunction drug, for the treatment of vascular dementia.

AES: More Rxs for opioid painkillers held by epilepsy patients than by general population

Formulary managers should be alert to the use of opioid painkillers by special populations, such as people with epilepsy, according to findings during a poster session at the American Epilepsy Society annual meeting in Seattle.

Post-stroke drug combo linked to lower risk of stroke recurrence

Dr OvbiageleFor recent ischemic stroke patients, using an optimal combination of evidence-based secondary prevention medication classes, compared to not doing so, was associated with 61% lower odds of experiencing a recurrent stroke, according to a study published online in Neurology.

FDA approves first drug to treat patients with a chronic type of bone marrow disease

FDA approved a new use for ruxolitinib (Jakafi, Incyte) to treat patients with polycythemia vera (PV), a chronic type of bone marrow disease. Jakafi is the first drug approved by FDA for this condition.

ASH: 6-year data reinforce superiority of nilotinib over imatinib in newly-diagnosed patients with Ph+ CML

Nilotinib (Tasigna) should be considered as a leading option for front-line therapy in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), according to data presented at the 56th ASH Annual Meeting and Exposition in San Francisco.

FDA panel recommends Actavis' antibiotic for approval

Actavis Plc has announced that the Infective Drugs Advisory Committee, which makes recommendations to the FDA concerning the safety and effectiveness of drug products for use in the treatment of infectious diseases, has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.

Possible link between statin use and cataracts, but weigh risks and benefits

Patients taking statins may be at an increased risk for cataracts, according to a study published in the Canadian Journal of Cardiology.