Remicade Recommended for Approval by FDA
The U.S. Food and Drug Administration's Arthritis Advisory Committee has voted unanimously to recommend approval of Centocor's Remicade (infliximab) with methotrexate for the reduction of structural damage in rheumatoid arthritis patients.

Remicade with methotrexate is currently approved for rheumatoid arthritis patients who have an inadequate response to methotrexate alone. Studies have shown that Remicade has the potential to have a positive effect on joint space narrowing and bone erosions. Treatment with Remicade also improved patients' abilities to perform everyday tasks, according to a company news release.

FDA Recommends Approval of IBS Drug The U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee has recommended approval for Zelmac (tegaserod) by Novartis Pharmaceuticals for the treatment of abdominal pain or discomfort and constipation in women with irritable bowel syndrome (IBS). Currently, there is no effective treatment for patients suffering from these symptoms, according to a company news release.

Zelmac belongs to a new chemical class of compounds that selectively targets and acts on 5-HT₄ receptors present throughout the GI tract, according to the company. These serotonin receptors may play a key role in pain perception and GI motility. Zelmac may reduce pain and normalize function in IBS patients who suffer from abdominal pain and constipation as their primary symptoms by acting on the 5-HT₄ receptor pathway.

Drug Approved for Premen- strual Dysphoric Disorder
The U.S. Food and Drug Administration has approved Sarafem (fluoxetine) by Eli Lilly and Co. for the treatment of premenstrual dysphoric disorder (PMDD).

Sarafem is the only prescription medication indicated specifically for the treatment of PMDD. Women treated with Sarafem experienced statistically significant improvement in mood and physical symptoms in clinical studies. Women in the studies also experienced significant improvement in social functioning compared with women taking placebo, according to the company. These improvements were present by the first menstrual cycle on treatment.

Sarafem contains fluoxetine HCl, the same active ingredient found in the popular antidepressant Prozac.

New Lotion as Effective as Gel for Rosacea
MetroLotion (metronidazole lotion) Topical Lotion, 0.75%, by Galderma Laboratories, a new lotion formulation of topical metronidazole 0.75% recently introduced for the treatment of rosacea, has been found in a recent clinical study to be comparable in effectiveness to MetroGel (metronidazole topical gel) Topical Gel, 0.75%, which is currently the most widely prescribed topical treatment for the condition, according to a company press release.

In this recent study, conducted at 10 medical centers, 114 patients with moderate to severe rosacea were treated with either the metronidazole lotion or the gel. After 12 weeks of treatment, patients using the lotion treatment had a mean decrease in inflammatory lesions of 73.9%, compared with a mean reduction of 70.2% in patients using the gel formulation.