New Rx, OTC, and generics (November 2009)

November 3, 2009

A survey of new Rx and new OTC

Key Points

New drugs

The FDA approved Meda's Astepro (azelastine) nasal spray 0.15% for treatment of symptoms of seasonal and perennial allergic rhinitis. The product, 50 percent more concentrated than the original Astepro, is dosed once a day. It is formulated with azelastine, a nasal antihistamine, and without an added decongestant such as pseudoephedrine. For more information, visit http://www.astepro.com/.

Shire announced FDA approval of once-daily Intuniv (guanfacine) extended-release tablets, a selective alpha-2A adrenergic receptor agonist, for the treatment of attention-deficit hyperactivity disorder in children and adolescents 6 to 17 years of age. Intuniv is not a controlled substance and has no known potential for drug abuse or dependence. For more information, call 800-536-7878 or visit http://www.intuniv.com/.

Meda announced the commercial availability of Edluar 5 mg and 10 mg sublingual tablets. Edluar is indicated for the short-term treatment of insomnia characterized by difficulty falling asleep. Edluar is the first available under-the-tongue formulation of zolpidem, the most prescribed treatment for insomnia. Visit http://www.edluar.com/ for more information.

Novartis announced that the FDA has approved Valturnatablets. Valturna combines in a single pill aliskiren, the active ingredient in Tekturna, and valsartan, the active ingredient in Diovan. Valturna, which offers significantly greater blood pressure reduction than either valsartan or aliskiren alone, is available in two strengths, 150 mg/160 mg and 300 mg/320 mg. For more information, visit http://www.novartis.com/.

OTC

Combe Inc. introduces Cepacol Fizzlers (benzocaine), a topical oral anesthetic for the relief of minor sore throat pain in children 5 to 12 years of age. Company literature states that the grape-flavored tablets dissolve rapidly on the tongue to provide fast pain relief. For more information, call 800-431-2610 or visit http://www.cepacol.com/.

CoCoCare is introducing Africare Cocoa Butter Hair Oil , formulated to correct, condition, and restore luster to hair; Africare Vitamin E Golden Hair Oil, formulated to vitalize hair, add body and control, and restore radiance; and Africare Olive Oil Hair Therapy, formulated to help repair weak and damaged hair while adding body and control. For more information, visit http://www.cococare.com/.

Schering-Plough has expanded the Claritin product line with Claritin 12-Hour RediTabs (loratadine), a nondrowsy antihistamine in a quick-dissolving tablet. Patients can choose either 12-hour or 24-hour allergy relief. Claritin 12-Hour RediTabs are indicated for the relief of allergy symptoms in adults and children six years of age or older. Visit http://www.claritin.com/.

Wein Products introduces Viramask N99ESC, a CDC/NIOSH-certified adhesion-respirator facemask that affords the wearer 99.9 percent protection against viruses and bacteria. One size fits all. The mask has the best leak-test rating of any mask in its class. It is totally strapless and can be used up to eight hours. For more information, call 718-601-6086.