The U.S. Food and Drug Administration has granted approval to Cypress Pharmaceutical, Inc.’s abbreviated new drug application for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL. This product is an AA-rated generic equivalent to the Zyrtec® Oral Solution developed by McNeil Consumer Healthcare. While Cetirizine HCl Oral Solution’s over-the-counter version is an antihistamine that relieve from indoor and outdoor allergies such as sneezing, runny nose, watery eyes and itchy throat; the prescription version treats symptoms of allergic rhinitis in children who are 6 to 23 months of age and relieve children up to 5 years of age from chronic urticaria (hives).

The US Food and Drug Administration has given approval to Wockhardt for manufacturing and marketing its Promethazine hydrochloride injection. The drug which is used for the treatment of allergy to blood or plasma; nausea, motion sickness and vomiting related to certain types of surgery and anesthesia will be available in the doses of  25 mg/ml and 50 mg/ml. The antihistamine gives relief from nasal stuffiness and inflamed eyes as a result of hay fever. Symptoms like itching, rashes and swelling are also taken care of.

Researchers at Macchi Hospital in Varese, Italy have proposed that sublingual immunotherapy (SLIT) can prove beneficial in preventing mild persistent asthma and new skin sensitizations in children suffering from allergic rhinitis. The doctors also report that the therapy has the potential to reduce bronchial hyperactivity. Based on the 3-year long study, SLIT was found to be safe for children, when used in the recommended doses.

The U.S. Food Drug and Administration has noted that a careful reading of food labels might not be sufficient to keep the sufferers of food allergy safe. In a public hearing, the agency indicated that a product could unintentionally contain trace amounts of an allergen, such as peanuts. “Advisory warnings confuse the consumers and do not help them in taking the right decision. The FDA wants to construct a long-term strategy to help producers use clearer advisory labels.

Grazax, the allergy immunotherapy developed by Schering-Plough and ALK-Abello, showed a 28% reduction in hay fever symptoms during its Phase III pediatric trial. According to Denmark-based ALK-Abello, the therapy led to a 64% reduction in the combined asthma symptom score as well. The previous European trial of Grazax displayed positive clinical effect. A Grazax pediatric registration application is currently under review in Europe.

Photo by marcbenton