Asthmatx Inc. has announced that the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the Alair® System, a device utilized in bronchial thermoplasty for the treatment of severe persistent asthma in patients 18 years and older, be found approvable with conditions. The final decision regarding the approval of the device is made by the FDA.

French biotech firm NicOx has submitted a new drug application (NDA) to the US regulatory authority for its anti-inflammatory drug naproxcinod. The naproxcinod drug is developed for the treatment of osteoarthritis. The marketing approval of the drug could deal a blow to sales of the Pfizer medicine Celebrex. The company also plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in the fourth quarter of 2009.

The FDA has approved a new biologic drug called Stelara for the treatment of moderate to severe plaque psoriasis in adults. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. According to the FDA, about 6 million people in the US have plaque psoriasis, which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

The FDA Vaccines and Related Biological Products Advisory Committee agreed on the efficacy, immunogenicity and safety data of Merck & Co Inc’s . The clinical trials support the use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and men aged 9 to 26 years for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

The FDA has approved injectible vaccine and a nasal spray vaccine for the 2009 H1N1. In fact, the results have been better than good. Four manufacturers, CSL Ltd, MedImmune LLC, Novartis Vaccines and Diagnostics Ltd and Sanofi Pasteur Inc, have been given the go-ahead to manufacture them. A study carried in Australia and another one by the US National Institutes of Health indicated that healthy adults got protection from the flu with just one dose of vaccine, instead of two doses. People showed “robust” protection against the virus after about eight to 10 days of getting the vaccine shot, according to the FDA. The Centers for Disease Control and Prevention expects about 45 million doses to be available by mid-October.

The FDA has approved GlaxoSmithKline’s Hiberix vaccine to prevent a disease caused by Haemophilus influenzae type b in children. The company said that it has received accelerated approval for Hiberix as a booster dose in children aged 15 months to four years due to the shortage of the vaccine protecting infants from Hib. Hib is a severe and potentially deadly bacterial infection that can cause meningitis. The vaccine is expected to be available within a few weeks.

Glenmark Generics Limited has received ANDA approval from the FDA for Alcometasone Dipropionate Ointment, 0.05%. Alcometasone Dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and manifestations of corticosteroid- responsive dermatoses. The company will commence marketing and distribution of this product in the US market immediately.

A recent study conducted by Genentech Inc suggested a disproportionate increase in heart attacks and strokes in patients treated with Xolair (omalizumab), compared to those who were not given the drug. The FDA had approved the drug in June, 2003 to treat patients aged 12 years or more with moderate-to-severe persistent allergic asthma unresponsive to inhaled steroids and is now conducting a safety review.

The FDA has advised people against using Zicam intranasal products containing zinc as these drugs might cause long-lasting or permanent anosmia (loss of the sense of smell. The following Zicam products come under the FDA warning:
•    Zicam Cold Remedy Nasal Gel
•    Zicam Cold Remedy Gel Swabs
•    Zicam Cold Remedy Swabs, Kids Size

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).