Lenalidomide (Revlimid - Celgene), a thalidomide analog, has been approved by the FDA for treatment of patients with transfusion-dependent anemia due to myelodysplastic syndrome (MDS) associated with a 5q deletion cytogenetic abnormality and a low or low-intermediate risk of mortality and progression to leukemia (based on the International Prognostic Scoring System).

An intraveneous (IV) formulation of ibuprofen (Caldolor - Cumberland) was recently approved by the FDA for use in adults. It can be administered alone for treatment of mild to moderate pain or as an adjunct to opioid analgesics for moderate to severe pain. It is also approved for reduction of fever.

The FDA has approved Fortesta (Endo), a topical gel, for testosterone replacement therapy in adult males with hypogonadism. It is classified as a Schedule III controlled substance. Table 1 lists some available testosterone products, including 2 other gels.

The FDA has approved rilpivirine (Edurant – Janssen), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use with other antiretroviral agents for treatment of HIV-1 infection in treatment-naive adults. Rilpivirine is also available in a fixed-dose combination with emtricitabine and tenofovir (Complera – Gilead).

Bedaquiline (bed ak' wi leen; Sirturo – Janssen), a diarylquinoline antimycobacterial, has been given accelerated approval by the FDA as an orphan drug for use in addition to other drugs for treatment of adults with multidrug-resistant pulmonary tuberculosis (MDR-TB). It is the first drug approved specifically to treat MDR-TB.

The FDA has approved ferric carboxymaltose (Injectafer – American Regent), a 2-dose intravenous iron replacement product, for treatment of iron deficiency anemia (IDA) in adults who cannot tolerate or have had an unsatisfactory response to oral iron and in those who have non-dialysis-dependent chronic kidney disease (CKD). It is the sixth IV iron product approved in the US.

The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder. Levomilnacipran is the more active enantiomer of milnacipran (Savella), which was approved in 2009 for management of fibromyalgia. Fetzima has not been studied in fibromyalgia.

The FDA has approved another solution of the aminoglycoside antibiotic tobramycin (Bethkis – Chiesi/Cornerstone) for oral inhalation via a nebulizer for management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

The nasal spray formulation of the corticosteroid fluticasone propionate is now available over the counter (OTC) as Flonase Allergy Relief (GSK) in the same strength as the prescription product (Flonase, and generics) for patients ≥4 years old with seasonal or perennial allergic rhinitis. It is the second corticosteroid nasal spray to become available OTC; triamcinolone acetonide (Nasacort Allergy 24HR) was the first. Unlike prescription Flonase, the OTC product is FDA-approved for reduction of ocular as well as nasal symptoms. Brand-name prescription Flonase has been...

The FDA has approved use of Exablate Neuro (Insightec) for unilateral thalamotomy to treat medication-refractory essential tremor in patients ≥22 years old. Exablate Neuro uses magnetic resonance-guided focused ultrasound (MRgFUS) to create lesions in the ventral intermediate nucleus of the thalamus. MRgFUS is also approved in the US for treatment of uterine fibroids and for pain palliation of bone metastases.