The US manufacturer of varicella zoster immune globulin (VZIG; Massachusetts Public Health Biologic Laboratories, Boston, MA) recently discontinued its production. A Canadian formulation, VariZIG (Varicella Zoster Immune Globulin [Human] - Cangene Corporation, Winnipeg) is now available in the US under an investigational new drug application expanded access protocol.

Duloxetine (Cymbalta - Lilly) is the second drug to be approved by the FDA for treatment of fibromyalgia. Pregabalin (Lyrica), which is also approved for treatment of neuropathic pain and epilepsy, was the first. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) that is already marketed for treatment of depression and diabetic neuropathy.

The FDA has approved the marketing of alvimopan (Entereg - Adolor/GlaxoSmithKline), a selective muopioid receptor antagonist, for oral treatment of postoperative ileus after bowel resection. The only other drug in this class available in the US is subcutaneously injected methylnaltrexone (Relistor), which is approved for treatment of opioid-induced constipation in patients with advanced illness receiving palliative care.

Since publication of our recent article on antiviral drugs for influenza, increased levels of resistance to oseltamivir (Tamiflu) have been detected in influenza A H1N1 strains.

The FDA has approved a delayed-release capsule formulation of valproic acid (VPA; Stavzor - Noven Therapeutics) for all of the indications for which divalproex sodium (Depakote, and others; Depakote ER) is approved: monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures, and adjunctive therapy in patients with multiple seizure types that include absence seizures; acute treatment of manic episodes associated with bipolar disorder; and prophylaxis of migraine headaches. In addition, valproate (valproic acid or divalproex sodium) is considered a...

Axona (Accera), a "medical food" containing a proprietary formulation of medium-chain triglycerides (>95% caprylic triglyceride), is currently being marketed for the "clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease."

The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the pathogenesis of many systemic inflammatory disorders.

The FDA has approved racemic amphetamine sulfate (Evekeo – Arbor) for oral treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥3 years old. It was also approved for treatment of narcolepsy in patients ≥6 years old and for short-term treatment of obesity in patients ≥12 years old.

Per capita spending on prescription drugs in the US is higher than in other industrialized nations, including Canada.

The FDA has approved ritlecitinib (Litfulo – Pfizer), an oral JAK and TEC kinase family inhibitor, for treatment of severe alopecia areata in patients ≥12 years old. Ritlecitinib is the second oral drug to be approved in the US for treatment of severe alopecia areata; baricitinib (Olumiant), a JAK inhibitor, is approved only for use in adults.