An IV formulation of pantoprazole sodium (Protonix IV - Wyeth-Ayerst), a benzimidazole proton pump inhibitor (PPI), has been approved by the FDA for short-term treatment of Zollinger-Ellison Syndrome (ZES) and gastroesophageal reflux disease (GERD) in patients who cannot take oral drugs. Pantoprazole is the first PPI to be approved for IV use in the US.

Tadalafil (Cialis - Lilly Icos) is the third oral drug to be approved by the FDA for treatment of erectile dysfunction. It has a longer duration of action than sildenafil (Viagra) or vardenafil (Levitra - Medical Letter 2003; 45:77).

Mecasermin (Increlex - Tercica), which is injected subcutaneously, has been approved by the FDA for treatment of growth failure in children with severe primary insulin-like growth factor (IGF-1) deficiency. Mecasermin is recombinant human (rh) IGF-1. It has also been approved to treat children with short stature who are deficient in growth hormone (GH), but have developed neutralizing antibodies in response to GH treatment. A similar product, mecasermin rinfabate (Iplex - Insmed), that was approved by the FDA for the same indications was withdrawn from the market due to patent...

Resveratrol is a phytochemical found in the skin of red grapes and in many other plants, including berries, plums and peanuts. As a constituent of red wine, it has been associated with cardioprotective effects. Dietary supplements containing resveratrol are now being widely promoted as antioxidants that can prevent agerelated diseases.

Vilazodone (Viibryd – Forest), a selective serotonin reuptake inhibitor (SSRI) and partial 5-HT_1A receptor agonist, has been approved by the FDA for treatment of depression. It has been claimed to have no sexual side effects and not to cause weight gain.

The FDA has approved indacaterol (in´´ da ka´ ter ol; Arcapta Neohaler – Novartis), an inhaled long-acting beta₂-agonist, for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Indacaterol is not approved for treatment of exacerbations of COPD or for treatment of asthma. It has been available in Europe as Onbrez Breezhaler since 2009.

The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).

The FDA has approved a new formulation of carbidopa/levodopa (Rytary – Impax) in extended-release capsules for treatment of Parkinson’s disease (PD).

The FDA has approved ceftazidime/avibactam (Avycaz – Actavis) for IV treatment of complicated urinary tract and intra-abdominal infections in adults who have limited or no other treatment options. Ceftolozane/tazobactam (Zerbaxa – Cubist), another cephalosporin/beta-lactamase inhibitor combination, was approved in 2014.

A patient-controlled fentanyl iontophoretic transdermal system (Ionsys – The Medicines Company) is now available for short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. Before using Ionsys, patients must be titrated to a comfortable level of analgesia with another opioid formulation.