News

FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations

FDA approved filgrastim-sndz (Zarxio, Sandoz), the first biosimilar product approved in the United States.

Paracetamol (acetaminophen) is still safer than nonsteroidal anti-inflammatory drugs (NSAIDs), but there is concern about its potential for some side effects not usually considered related to paracetamol, according to a study published in the Annals of Rheumatic Diseases.

Cresemba (isavuconazonium sulfate, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.

A Geisinger Health Plan telemonitoring program for heart failure patients significantly reduced hospital readmissions, cut the cost of care for members, improved the efficiency of care managers and delivered a 3.3 return on investment, according to a new study.

Because the use of corticosteroids in patients with severe community-acquired pneumonia is controversial, researchers in Spain set out to determine the benefits versus the pitfalls of using the adjunctive therapy.

The anticoagulant medication Fondaparinux (Arixtra) was associated with reduced major bleeding events and improved survival, compared to low-molecular-weight heparin (LMWH) in a large randomized clinical trial involving patients with non–ST-segment elevation myocardial infarction (NSTEMI), according to a new study.

FDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.

FDA has expanded the approved use of nivolumab (Opdivo, Bristol Myers Squibb) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

FDA has launched its first mobile application (app) designed to provide quick access to important information on medications that are in short supply. Current or resolved drug shortages, as well as product discontinuations, can be identified by using the new app.

A new nanodevice developed by MIT researchers can help prevent cancer tumors from growing back after chemotherapy, according to a new study published in the Proceedings of the National Academy of Sciences for the week of March 2.

A national survey of pharmacy professionals released March 3 found that a move to specialty drug distribution of three primary cancer drugs is resulting in higher costs to hospitals and reduced availability of the medications.

Xolair (omalizumab), a drug used to treat allergic asthma in adults and children 12 years and older, has been linked to significant health issues such as mini-strokes, heart attacks and blood clots, according to the law firm of Baron and Budd, which has offices in Dallas, Texas, and several other cities.

Among patients receiving antithrombotic therapy (to prevent the formation of blood clots) after a heart attack, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with an increased risk of bleeding and events such as heart attack, stroke or cardiovascular death, even after short-term treatment, according to a study in the February 24 issue of JAMA.

FDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.

A bill has been introduced in California which will require drug companies to reveal operational costs in order to better understand pricing for ultra-high-priced drugs.

Pediatric cancer patients who receive antibiotics within 60 minutes of reporting fever and showing neutropenia (low neutrophil count), go on to have decreased intensive care needs and lower mortality compared with patients who receive antibiotics outside the 60-minute window, according to a University of Colorado Cancer Center study published in Pediatric Blood & Cancer.

FDA has approved a new once-daily, long-acting basal insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL, Sanofi) for the treatment of adults with type 1 and type 2 diabetes mellitus. It is described as a more potent follow-up to the manufacturer’s insulin product Lantus (insulin glargine [rDNA origin] injection, 100 U/mL).

FDA has approved ceftazidime-avibactam (Avycaz, Actavis and Forest), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

The oral formulations of the antifungal medication ketoconazole should be removed from the market immediately, Public Citizen said this week in a petition to the Food and Drug Administration (FDA).

Kaiser Permanente Southern California's population-based program for men with prostate cancer has led to improved outcomes, according to a study published in Urology Practice.

Most treatments for pain caused by knee osteoarthritis helped alleviate pain better than acetaminophen (Tylenol) – with one exception, according to a study published in the January 6 issue of the Annals of Internal Medicine

The prostate cancer medication leuprolide acetate (Lupron Depot), used in conjunction with acetylcholinesterase inhibitor (AChEI), slowed memory loss in female Alzheimer’s patients, according to a new study.

Resistance to the malaria medication artemisinin extends across much of Myanmar in Southeast Asia, according a new study, published online February 19 in The Lancet Infectious Diseases.

Patients who increased doses of opioid medicines to manage chronic pain were more likely to experience an increase in depression, according to a study published in the February issue of Pain.

The VenaSeal system is newly approved to permanently treat varicose veins by sealing the affected veins using an adhesive agent, known as n-butyl-2-cyanoacrylate, which polymerizes into solid material after being injected into the vein.

Actavis has received final approval from FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2 mg and 8 mg sublingual tablets) indicated for treatment of opioid dependence.

FDA approved Farydak (panobinostat) for the treatment of patients with multiple myeloma, which is attributed to 10,710 deaths in the U.S. annually.

FDA has authorized marketing of Bloom Syndrome carrier test, a direct-to-consumer genetic test from 23andMe.The test is designed to identify healthy individuals who carry a gene that could cause Bloom Syndrome in their offspring.

The introduction of high-cost, high-use PCSK9 inhibitors (proprotein convertase subtilisin/kexin 9) enzyme inhibitors to treat high cholesterol, takes the industry step closer to a future where “healthcare costs break the bank,” according to industry insiders.