FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies

The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.

Dräger Issues Voluntary Nationwide Recall of Optional PS500 Power Supply for Evita V500 and Babylog VN500 Ventilators

Today Dräger initiated a nationwide recall of the optional PS500 Power Supply Unit used with the Evita V500 and Babylog VN500 ventilators. This voluntary action was a result of an internal investigation by Dräger into complaints that found that the batteries installed in the PS500 depleted much earlier than expected, although the battery indicator showed a significantly charged battery.

Nova Products, Inc. Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical Ingredients

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level. Lot numbers are identified on the back or side of each product. FDA laboratory analysis on these products has determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.

FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B

The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

FDA approves Topamax for migraine prevention in adolescents

Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.