News

FDA has approved abacavir 600 mg, dolutegravir 50 mg (Tivicay) and lamivudine 300 mg (Triumeq, ViiV Healthcare) as as a first-line therapy to treat HIV.

Zorvolex was the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. By using this technology, the dose can be lowered without delaying absorbtion.

Almost half of disabled workers enrolled in Medicare’s prescription drug program fill a prescription for opioids each year, and more than 1 in 5 were chronic users, filling 6 or more opioid prescriptions each year, according to a study in the September issue of Medical Care.

Precedex, dexmedetomidine hydrochloride, is approved to sedate patients with breathing tubes in an intensive-care setting, as well as patients without breathing tubes before and during surgeries and other procedures. Hospira’s patent that covers the use of Precedex in an intensive-care setting in due to expire in 2019, however other patents have already expired. On Monday, the FDA approved the sale of generic copies of the drug as long as the companies leave out information from the prescribing labels about uses that are covered under Hospira’s patent, including “intensive-care unit sedation.”

FDA has approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE.

FDA has approved fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older.

FDA has approved suvorexant (Belsomra, Merck) for adults with insomnia who have difficulty falling asleep and/or staying asleep.

The World Health Organization (WHO) has authorized the use of experimental drugs in the Ebola outbreak in West Africa. The death toll has reached 1,000, including a Spanish priest.

The federal government’s cost for Medicare Part D will increase between $2.9 billion and $5.8 billion if we see 15% to 30% of hepatitis C (HCV)-infected beneficiaries receive treatment in 2015 and the cost of treatment averages $84,000, according to a new study by Milliman.

Widespread anticoagulant undertreatment persists among atrial fibrillation (AFib) patients at high risk of stroke, despite current medical treatment guidelines, which recommend thromboprophylaxis for this patient population unless contraindicated, according to a recent study in BMC Health Services Research.

FDA has approved oritavancin (Orbactiv, The Medicines Company) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Hetlioz (tasimelteon) is a melatonin receptor agonist, similar to Rozerem (ramelteon) that was approved by FDA in January 2014 for the treatment of N24HSWS caused by a completely blind person’s inability to regulate their internal clock.

FDA approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).