Improved glucose meters and 2 sensing systems for continuous monitoring have become available for management of diabetes.

The FDA has approved Dyloject (Hospira), an IV formulation of the NSAID diclofenac sodium, for use in adults. It can be administered alone for treatment of mild to moderate pain or in combination with opioid analgesics for moderate to severe pain. Dyloject is the first injectable formulation of diclofenac to become available in the US.

The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as Engerix-B and is licensed for use only in adults.

The results of a clinical trial (PRECISION) comparing the cardiovascular safety of the COX-2 selective NSAID celecoxib (Celebrex, and generics) with that of ibuprofen and naproxen, which are nonselective, have been described in the lay press in terms that may overestimate the safety of celecoxib.

A recent report in the New England Journal of Medicine suggested that in children with bacterial meningitis, adding the corticosteroid dexamethasone (Decadron; and others) to antibiotic treatment could decrease the incidence of moderate or severe hearing loss.

Vinorelbine (Navelbine - Burroughs Wellcome), a semisynthetic vinca alkaloid, has been approved by the US Food and Drug Administration for parenteral use in the treatment of advanced non-small-cell lung cancer (NSCLC). Various combinations of cisplatin (Platinol), vinblastine (Velban, and others), mitomycin (Mutamycin), ifosfamide (Ifex), etoposide (VePesid) and paclitaxel (Taxol) have been used previously for this indication.

Monitoring adherence of psychiatric patients to oral medication may be especially difficult. The FDA has approved Abilify MyCite (Otsuka/Proteus), an aripiprazole tablet with an embedded sensor that tracks when patients take the medication. It is indicated for treatment of adults with schizophrenia, bipolar disorder, or major depressive disorder. Abilify MyCite is the first drug with a digital ingestion tracking system to be approved in the US.

Dasatinib (Sprycel - Bristol-Myers Squibb), an inhibitor of multiple tyrosine kinases, has been approved by the FDA for second-line treatment of chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults.

Duetact (Takeda), a new fixed-dose combination of the thiazolidinedione pioglitazone (Actos) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved as an adjunct to diet and exercise to improve glycemic control in patients already taking pioglitazone and/or a sulfonylurea. Avandaryl, a combination of glimepiride and the thiazolidinedione rosiglitazone, was approved in 2006.

A once-daily oral formulation of mesalamine (Lialda - Shire) was recently approved by the FDA for induction of remission in patients with mild to moderate ulcerative colitis.