New products: Rx, generics, and OTC (January 2009)


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

Key Points


New drugs

Allergan Inc. has announced the nationwide availability of Aczone (dapsone) Gel 5 percent, a new, first-in-class topical treatment for inflammatory acne. Aczone Gel's topical formulation offers patients a convenient therapy that has proved effective. For more information, visit

Pfizer has announced the FDA has approved the anti-muscarinic agent Toviaz (fesoterodine fumarate) in extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Toviaz is structurally related to Pfizer's OAB medication Detrol LA (tolterodine tartrate extended-release capsules). The 4 mg and 8 mg doses of Toviaz allow dosing flexibility to optimize treatment based on individual patient response and tolerability. For more information, visit

New indication

Premarin (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the FDA for a new indication and a less-frequent, twice-weekly dosing regimen to treat moderate-to-severe postmenopausal dyspareunia (painful sexual intercourse). According to the company, a low-volume regimen of Premarin Vaginal Cream can treat painful intercourse due to menopause, restore vaginal tissue, and reverse changes in the vagina that occur with menopause. Visit for more information.

Novartis has announced that the FDA has approved a 30-minute onset of action for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of attention deficit/hyperactivity disorder (ADHD). The 30-minute onset of action can help children with ADHD improve their morning academic productivity in school, says the company. For more information, visit

New generics

Sandoz launched the generic version of Inspra (eplerenone) in the United States. Eplerenone is used to treat high blood pressure and heart disease, and will be marketed in 25- and 50-mg strengths. More information is available at

Sandoz also announced the introduction of sumatriptan injection, a generic equivalent of Imitrex. Sumatriptan is a triptan used to treat migraine headaches and helps to relieve pain and other symptoms, including sensitivity to light and sound, nausea, and vomiting. For information, visit or call (609) 627-8881.


Biocodex Inc., is offering Florastor, a probiotic treatment, in new 20-count blister packs designed to make treatment and prevention of antibiotic-associated diarrhea (AAD) more convenient. At two capsules per day, it coincides with the standard 10-day course of antibiotics. The new packaging was designed for shelf placement in retail chains. For more information, visit or

Carma Laboratories Inc., announced new Carmex Moisture Plus, a lip balm made with Vitamin E, aloe, shea butter, and avocado for intense moisturizing protection. The ultra-hydrating lip balm has an SPF rating of 15. For more information visit or call (414) 421-7707.

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