New products: Rx, Generics, OTC, HBC (November 2008)

November 10, 2008

A survey of new Rx, new OTC, new indications, and new generics

Rx Care

New Drug

Covidien launches TussiCaps Extended Release Capsules (hydrocodone polistirex/chlorpheniramine polistirex). TussiCaps, for cough suppression, is the only extended-release capsule formula that contains hydrocodone and chlorpheniramine, providing powerful cough suppression for up to 12 hours. According to the manufacturer, this new product, which contains a consistent dose of the medication, offers more precise and convenient dosing than liquid formulations. For more information visit http://www.covidien.com/ or call 441-298-2480.

DizzyFIX has been approved for sale in the United States by FDA. Made in Canada by Clearwater, DizzyFIX is an at-home treatment for vertigo and dizziness that helps guide patients through the Epley maneuver. According to its manufacturer, DizzyFIX will now be available by prescription in the United States. A low-cost, patent-pending dynamic visual-feedback device that easily attaches to a hat, DizzyFIX is geared to patients with benign paroxysmal positional vertigo (BPPV), one of the leading causes of dizziness, which affects as many as 10 percent of people older than 60. To learn more about DizzyFIX, visit http://DizzyFIX.com/ or call (877) 349-9934.

Sanofi-Aventis announced that the FDA has approved Nasacort AQ Nasal Spray (triamcinolone acetonide) for children ages 2 to 5 for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. Contact Sanofi-Aventis at (908) 981-6563.

OTC

Prestige Brands Holdings Inc. announces the launch of Chloraseptic Allergen Block and Little Allergies Allergen Block[2]. According to the company, these OTC products prevent nasal allergy symptoms by blocking allergens in the air on contact, before they enter the nasal passages. Topical gels that are applied around the outside of the nostrils to block both indoor and out door airborne allergens, they are sold at drug stores, mass merchandisers, and supermarkets. For more information on Allergen Block, visit http://www.allergenblock.com/.

Oregon Aesthetic Technologies announces the availability of ANSR: Acne Care [3], an acne treatment featuring clinically-proven phototherapy and topical ingredients to fight acne and heal the skin. Its manufacturer calls ANSR: Acne Care an evolutionary shift in at-home skin care, pointing to its use of phototherapy technology and powerful patent-pending topicals to build a comprehensive skin-care solution that addresses multiple causes and effects of acne, including excess skin-surface debris, oiliness, pore-clogging sebum, bacteria, inflammation, redness, and scarring. See http://www.ANSR.com/ for more information.

New Indication

Teva Pharmaceutical Industries Ltd. announced recently the FDA has approved ProAir HFA Inhalation Aerosol (albuterol sulfate) for use by patients as young as 4. Previously, ProAir HFA had been indicated for use in patients 12 and older. In clinical studies, ProAir HFA, a leading albuterol sulfate inhaler, exhibited significant bronchodilator efficacy in 4-to 11-year-old children with asthma. According to the company, ProAir HFA provides physicians with a treatment option to help relieve childrens' asthma symptoms as and wherever they occur, which is especially important as children return to school. Doctors, parents, and patients can find information about ProAir HFA at http://www.ProAirHFA.com/ and http://www.Switch2HFA.com/.

New Generics

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the FDA for its ANDA for Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Risperidone Tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen's Risperdal Tablets. For more information visit http://www.mylan.com/.