The FDA has asked the makers of Singulair, Accolate, Zyflo and Zyflo CR drugs to include the precaution regarding the reported changes in behavior and mood on their label. All these drugs are used to treat asthma and are leukotriene inhibitors, which affect the leukotriene pathway involved in the body’s response to inflammatory stimuli.

Teva Pharmaceutical’s ProAir HFA, an albuterol sulfate inhalation solution has received an expanded indication from the U.S. Food and Drug Administration for treating bronchospasm in children suffering with reversible obstructive airway disease. Previously approved for patients above 12 years of age, ProAir HFA is now recommended for patients older than 4 years. The indication was expandedc on the basis of a 3-week long study which concluded that 2 inhalations of the solution 4 times a day treated the symptoms significantly.

Schering-Plough Corp. has received FDA approval for Asmanex Twisthaler, 110 micrograms, as a preventive therapy for asthma in kids between 4 and 11 years of age. This treatment is the first once-daily inhaler that can be used for treating children as young as 4. The FDA had approved Asmanex 220 micrograms on March 31, 2005, for preventing asthma flare-ups in patients who are 12 years or older.

Taro Pharmaceutical Industries Ltd. has received FDA approval for its NDA (New Drug Application) for Flo-Pred (prednisolone acetate oral suspension) in its NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent used in the treatment of asthma, certain allergic and dermatologic conditions as well as various other indications. Taro expects to launch the product later this year. Adverse reactions common to corticosteroids include fluid retention, high blood pressure, high blood sugar, mood swings and weight gain.