ClassName/CompanyApproval Dates and Comments

Loratadine Dry Syrup 1%
Japan’s regulatory authority, the MHLW/KIKO, approved this once-a-day nonsedating antihistamine in October 2007 for the treatment of allergic rhinitis, urticaria and pruritus associated with skin diseases in children

Antiviral Agent
Valacyclovir Hydrochloride

TEVA Pharmaceutical Industries
The US FDA has granted tentative approval for an Abbreviated New Drug Application in October 2007 for TEVA Pharmaceutical Industries to market its generic version of GlaxoSmithKline’s antiviral product valacyclovir hydrochloride (Valtrex®) tablets for the treatment of herpes zoster and genital herpes.

Drug News

Anti-dandruff Agent
In January 2008, Head & Shoulders® Conditioner (Procter & Gamble), the first OTC anti-dandruff conditioner containing the active ingredient pyrithione zinc, will be available.

Anti-acne Agent
In October 2007, JSJ Pharmaceuticals launched two additional formulations of its anti-acne product line, Inova 8 and Inova 8/2 ACT, which incorporate benzoyl peroxide 8% alone or in combination with salicylic acid 2%. Both preparations use the EasyPad technology that allows for leave-on single unit dosing.

Anti-acne Agent
Study results recently published in Experimental Biology and Medicine* provide a possible explanation for the controversial link between isotretinoin (Accutane®/ Roaccutane®, Hoffmann La-Roche/ Roche) and depression. Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Researchers have unveiled the potential for isotretinoin to reduce the availability of serotonin (5-HT), a neurotransmitter implicated in the regulation of emotional responses, moods, sleep, and other physiologic and neurologic functions. Reduced levels of 5-HT are believed to trigger aggressive behavior and the onset of clinical depression. Prior to the release of these study findings, the association between isotretinoin and depression was suspected, however, until now, the precise relationship could not be established. The research found that the drug altered the chemistry of the cells that manufactured serotonin and interfered with the process by which the neurotransmitter directs signals between neurons in the central nervous system. Additional research is required to further explore the link and understand the precise mechanism of action.
*O’Reilly KC, et al. Exp Biol Med 232(9):1195-203 (2007 Oct).

A large prospective French study uncovered a potential link between an elevated risk of melanoma and a history of endometriosis. The study, recently published in the Archives of Internal Medicine*, examined 91,965 women between the ages of 40-65, who were tracked for 12 years via completion of questionnaires every 2 years. Study findings included the identification of 363 cases of melanoma, along with evidence suggesting that a history of ovarian cysts, uterine polyps, breast adenoma, breast fibroadenoma, or breast fibrocystic disease did not pose an increased risk of developing melanoma. However, a history of endometriosis (n=5,949) indicated a considerably higher risk of melanoma (relative risk: 1.62; 95% confidence interval (CI): 1.15-2.29). An increased risk also appears to exist among women with a history of fibroma (n=24,375), as compared with those without such a history (relative risk: 1.33; 95% CI: 1.06-1.67). These results may warrant heightened attention by physicians toward patients fitting the profile described in an effort to improve the early detection and management of melanoma.*Kvaskoff M, et al. Arch Intern Med 167(19):2061-5 (2007 Oct 22).