Vyalev (Abbvie), a solution for continuous subcutaneous infusion containing the prodrugs foscarbidopa and foslevodopa, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Vyalev is the first subcutaneously administered product to become available in the US for treatment of PD symptoms. Duopa, a carbidopa/levodopa enteral suspension infused via a nasojejunal tube or percutaneous gastrostomy, was approved in for the same indication 2015.

Coenzyme Q10, a fat-soluble antioxidant also known as ubidecarenone, ubiquinone and CoQ10, is marketed as a dietary supplement in the US, both as a single ingredient and in various combination products.

Adenosine (Adenocard - Fujisawa), an endogenous purine nucleoside, was recently approved by the US Food and Drug Administration for intravenous treatment of paroxysmal supraventricular tachycardia, including Wolff-Parkinson-White (WPW) syndrome. Adenosine is not approved for and has not been effective in treating atrial flutter, atrial fibrillation, or ventricular tachycardias.

(Ceredase - Genzyme) a modified form of the glycoprotein enzyme glucocerebrosidase prepared from human placenta, was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of patients with the non-neurologic form of Gaucher's disease (Type 1).

Methadone, an opioid agonist that can be taken orally, has been used for maintenance treatment for many years in the USA (DM Novick et al, Drug Alcohol Depend, 33:235, 1993). Last year, the US Food and Drug Administration approved the distribution and use of L-alpha-acetyl-methadol (LAAM; ORLAAM - Bio Development Corporation, McLean, VA), a long-acting congener of methadone. LAAM, like methadone, will be available for this indication only through federal and state-regulated treatment programs.

The FDA has approved the marketing of Natazia (Bayer), a 4-phase oral contraceptive containing the estrogen estradiol valerate and the progestin dienogest, both used for the first time in the US for this indication.

The FDA has approved ipilimumab (Yervoy – Bristol-Myers Squibb), a recombinant human monoclonal antibody, for treatment of unresectable or metastatic melanoma.

The labeling of dabigatran etexilate (Pradaxa – Boehringer Ingelheim), an oral direct thrombin inhibitor, has recently been updated to include new dosing and monitoring recommendations and a warning on the risk of bleeding. Dabigatran etexilate was approved in the US in 2010 for the prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been shown to be more effective than warfarin (Coumadin, and others) for this indication.

In 2011, the FDA asked the manufacturers of the selective serotonin reuptake inhibitor (SSRI) citalopram (Celexa, and generics) to lower the maximum daily dosage of the drug because of a dose-related increase in the QT interval. Since then, some of our readers have asked whether escitalopram (Lexapro, and generics), the active enantiomer of citalopram, could have the same effect.

Ocriplasmin (Jetrea – ThromboGenics) was recently approved by the FDA as an intravitreal injection for treatment of symptomatic vitreomacular adhesion. It is the first drug to be approved in the US for this indication.