A device that stimulates the vagus nerve was approved by the FDA in July 1997 for treatment of refractory epilepsy and is now considered "approvable" for treatment-resistant depression.

Deferasirox (Exjade - Novartis), an oral chelating agent, recently received accelerated approval from the FDA as an orphan drug for oral treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients >2 years old. Deferasirox is a tridentate (2 molecules of deferasirox bind to one atom of iron) chelating agent with high affinity for iron. It has much lower affinity for zinc and copper.

Spinal decompression machines offer a motorized form of mechanical traction. These devices, which are widely advertised to the public as a noninvasive alternative to surgery, are claimed to relieve low back pain by decompressing discs, improving the flow of nutrients into the disc and rehydrating dried-out discs. Devices cleared by the FDA based on substantial similarity to previously approved power traction devices include the Accu- Spina System, DRS System, DRX9000, Lordex Traction Unit, Spinal Health Elite, SpineMED Decompression Table, SpineRx-LDM and VAX-D Therapeutic Table.

The FDA has approved rivaroxaban (Xarelto – Janssen), an oral direct factor Xa inhibitor, for prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery.

The FDA has approved idelalisib (Zydelig – Gilead), an oral kinase inhibitor, for use in combination with rituximab (Rituxan) for treatment of relapsed chronic lymphocytic leukemia (CLL). It is also approved as monotherapy for treatment of relapsed follicular lymphoma and relapsed small lymphocytic lymphoma (both are subtypes of indolent non-Hodgkins lymphoma) in patients who have received at least two prior systemic therapies.

The FDA has approved two new long-acting injectable formulations of second-generation antipsychotics for treatment of schizophrenia: aripiprazole lauroxil (Aristada – Alkermes), which is given once every 4-6 weeks, and paliperidone palmitate (Invega Trinza – Janssen), which is given once every 3 months. Once-monthly injectable formulations of aripiprazole (Abilify Maintena) and paliperidone palmitate (Invega Sustenna) were approved earlier.

The anthracycline doxorubicin with or without the alkylating agent ifosfamide is the standard first-line treatment for advanced soft-tissue sarcomas. The FDA recently approved the minor groove DNA intercalator trabectedin (Yondelis – Janssen) for treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients previously treated with an anthracycline. Trabectedin has been available for years in Europe for treatment of advanced soft-tissue sarcoma. The FDA has also approved the microtubule inhibitor eribulin mesylate (Halaven – Eisai), which was approved earlier for...

Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not comment on the safety or effectiveness of their products beyond the date on the label. Since our last article on this subject, more data have become available.

The FDA has approved vamorolone (Agamree – Catalyst), an oral corticosteroid, for treatment of Duchenne muscular dystrophy (DMD) in patients ≥2 years old. Vamorolone is the second oral corticosteroid to be approved in the US for treatment of DMD; deflazacort (Emflaza) was approved in 2017.

The US Food and Drug Administration recently approved the marketing of G-CSF (recombinant human granulocyte colony-stimulating factor, generic name filgrastim, Neupogen - Amgen) and GM-CSF (recombinant human granulocyte-macrophage colony-stimulating factor, generic name sargramostim, Leukine - Immunex, Prokine - Hoechst-Roussel). G-CSF is approved for use after cancer chemotherapy in patients with non-myeloid malignancies to decrease the incidence of infection. GM-CSF is approved for acceleration of myeloid recovery after autologous bone marrow transplantation in non-Hodgkin's lymphoma,...