Boxed warning removed from ICS/LABA combos
The boxed warning regarding asthma-related deaths has been removed from the labeling of medications containing both an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA). Four large clinical safety trials show that treating asthma with a LABA in combination with an ICS does not result in significantly more serious asthma-related adverse reactions than treatment with an ICS alone.
The studies also showed that the ICS/LABA combination reduced asthma exacerbations compared with an ICS alone, and the new efficacy information has been added to product labeling.
The FDA notes that using LABAs alone to treat asthma without an ICS to treat lung inflammation is associated with an increased risk of asthma-related death; therefore, the boxed warning stating this will remain on the labels of all single-ingredient LABAs, which are approved to treat asthma, chronic obstructive pulmonary disease, and wheezing caused by exercise. Product labels containing both an ICS and a LABA also retain a warning and precaution related to the increased risk of asthma-related death when a LABA is used without an ICS to treat asthma.
New antimicrobial cream for impetigo
The FDA has approved ozenoxacin (Xepi) 1% cream for treatment of impetigo due to Staphylococcus aureus and Streptococcus pyogenes in patients age 2 months and older.
The approval was based on data from two phase-3 multicenter, randomized, double-blind, vehicle-controlled trials that enrolled 877 patients age 2 months and older with impetigo. Ozenoxacin was superior to placebo on the prespecified clinical and bacteriologic endpoints in the studies. By the end of the treatment period, 90.8% of patients who underwent treatment with ozenoxacin achieved bacterial eradication or presumed eradication compared with 69.8% of patients in the placebo group.
New medications approved for type 2 diabetes
The FDA has approved ertugliflozin for the treatment of type 2 diabetes mellitus (T2DM) as well as ertugliflozin as part of two new fixed-dose combinations for treatment of T2DM.
* Ertugliflozin (Steglatro), an oral sodium glucose cotransporter 2 inhibitor, is approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.
* Ertugliflozin and sitagliptin (Steglujan) is a fixed-dose combination tablet approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM when treatment with both ertugliflozin and sitagliptin is appropriate.
* Ertugliflozin and metformin hydrochloride (Segluromet) has been approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.
These medications are not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Ertugliflozin is contraindicated in patients with severe kidney impairment, end-stage renal disease, or those receiving dialysis.
Triclosan and 23 OTC antiseptics banned
The FDA finalized a rule banning the marketing of over-the-counter (OTC) healthcare antiseptic products containing triclosan or any of the other 23 other active ingredients in hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin products. The agency said these ingredients are not generally recognized as safe and effective, as the manufacturers of these products have failed to provide additional safety and efficacy data to the FDA.
Products containing these active ingredients must now undergo premarket review, and the FDA will consider the products to be new drugs, requiring manufacturers to gain approval through new drug applications. The action only concerns OTC products commonly marketed to healthcare providers and used primarily in medical settings.
The final rule does not affect healthcare antiseptics currently marketed under new drug applications as well as abbreviated new drug applications.