The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

The FDA has approved Durlaza (New Haven Pharmaceuticals), a 24-hour extended-release (ER) aspirin formulation available only by prescription, for secondary prevention of myocardial infarction (MI) and stroke.

The FDA has approved Fluad (Seqirus), an adjuvanted trivalent seasonal influenza vaccine, for immunization of adults ≥65 years old. It will become available later this year for use during the 2016-2017 influenza season. Fluad is the second influenza vaccine to be approved in the US specifically for older adults; Fluzone High-Dose was the first. Fluad has been available in other countries for many years.

The FDA has approved eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist and delta-opioid receptor antagonist, for oral treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).

The recent increase in deaths due to overdose of heroin and prescription opioids in the US has renewed interest in the opioid antagonist naloxone, particularly in making it available to first responders and to relatives and close friends of persons using heroin or taking prescription opioids. IV or IM administration by healthcare professionals is preferred, but peripheral venous access may be difficult to obtain in IV drug abusers, and exposure to their blood may be hazardous.

Homeopathic drugs characteristically consist of very large dilutions of "proven" substances. Serial dilutions of 1:10 are designated by the Roman numeral X. ColciGel (Gensco), a prescription homeopathic gel containing a 10,000-fold dilution of colchicine (colchicinum 4X), is now being marketed for topical treatment and prophylaxis of gout.

The FDA has approved the use of ambrisentan (Letairis) and tadalafil (Adcirca) together for treatment of pulmonary arterial hypertension (PAH). It is the first 2-drug regimen to be approved for this indication.

Harvoni, a once-daily fixed-dose combination of the direct-acting antiviral agents ledipasvir and sofosbuvir approved by the FDA in 2014 for treatment of hepatitis C virus (HCV) genotype 1 infection,1 has now been approved for use in patients infected with HCV genotype 4, 5, or 6, and in patients co-infected with HCV and HIV-1. A 12-week course of treatment with Harvoni plus ribavirin has also been approved as an alternative to 24 weeks of Harvoni alone for treatment-experienced, cirrhotic patients with HCV genotype 1 infection.HCV genotypes 4, 5, and 6 are responsible for <2% of HCV cases...

The FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) and metformin (Glucophage, and others), for treatment of patients with type 2 diabetes not adequately controlled on either of these drugs alone or already being treated with both empagliflozin and metformin. It is the third SGLT2 inhibitor/metformin combination to be approved in the US.

In 2007, an FDA advisory committee asked that placebo-controlled, dose-ranging trials be conducted to establish the efficacy of the oral decongestant phenylephrine (Sudafed PE, and others), which is sold over the counter (OTC) as a single agent and in combination with other drugs for treatment of cold and allergy symptoms. Phenylephrine replaced pseudoephedrine (Sudafed, and others) in many OTC formulations when access to pseudoephedrine-containing products was restricted in an effort to reduce their use in the synthesis of methamphetamine.CLINICAL STUDIES — In a randomized, open-label,...