The FDA has approved a new formulation (Exparel – Pacira) of the local anesthetic bupivacaine (Marcaine, and others) for use in the management of postsurgical pain in adults.

Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. It is the fourth oral tyrosine kinase inhibitor to be approved for treatment of advanced renal cell carcinoma.

The FDA has approved the antiparasitic drug ivermectin in a 0.5% lotion (Sklice – Sanofi Pasteur) as a single-use topical treatment for head lice in patients ≥6 months old. Oral ivermectin (Stromectol – Merck) is effective for treatment of head lice resistant to other therapies, but it has not been approved by the FDA for this indication.

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. It was approved under the Animal Efficacy Rule, which allows the FDA to approve drugs that demonstrate efficacy in animals, providing that they would have a reasonable human health benefit and are safe for human use. Raxibacumab is only available from the...

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.

Apremilast (Otezla – Celgene), an oral phosphodiesterase type-4 (PDE4) inhibitor, has been approved by the FDA for treatment of active psoriatic arthritis in adults. It is the fi rst PDE4 inhibitor to be approved for this indication.

Eslicarbazepine acetate (Aptiom – Sunovion) has been approved by the FDA for adjunctive treatment of partial-onset seizures in adults. New drugs for epilepsy are often approved by the FDA initially only as adjunctive treatment for partial seizures. Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the S-isomer of the active metabolite of oxcarbazepine. Oxcarbazepine itself is similar to carbamazepine. Both oxcarbazepine and carbamazepine are available generically.

The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

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.