New Products: Rx, generic, OTC (September 2008)

September 15, 2008

A survey of new drugs, new indications, new formulations, new generics, new OTC, and new products.

Key Points

Rx

New Drugs

Quinnova Pharmaceuticals Inc. ( http://www.quinnova.com/) launched Cleanse and Treat, the first prescription acne medication with a two-sided pad system (One + One Technology). One side of the pad contains a leave-on cleanser (salicylic acid 2 percent) and the other side of the pad contains a leave-on treatment (benzoyl peroxide 5 percent). The leave-on cleanser effectively removes dirt and oil while simultaneously delivering the active ingredient to exfoliate the skin. The reverse side of the Cleanse and Treat pad contains benzoyl peroxide, an effective treatment in killing P. acnes and reducing inflammation.

New Indications

Rituxan ( http://www.rituxan.com/) from Genentech is the first and only C-D-20-positive B-cell-targeted biologic for rheumatoid arthritis (RA). The FDA approved the drug in combination with methotrexate to slow the progression of structural damage in adult patients with moderate to severe active RA who have shown inadequate response to one or more tumor necrosis factor inhibitors.

Merck and Co. ( http://www.merck.com/) received FDA approval for an expanded label for Cancidas, which makes it the first and only echinocandin therapy approved in the United States for the treatment of pediatric patients aged 3 months to 17 years with indicated fungal infections. The therapy is now indicated in adults and pediatric patients (3 months and older) for empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and candida-caused intra-abdominal abscesses, peritonitis, and pleural space infections; treatment of esophageal candidiasis; and treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).

New Formulations

The FDA approved two single-pill combination medications from Novartis ( http://www.pharma.us.novartis.com/), Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan), as initial or first-line therapies in patients who may require multiple drugs to achieve blood-pressure goals. Diovan HCT combines in one tablet Diovan (valsartan), a high blood pressure medication, and hydrochlorothiazide, a high blood pressure treatment from the diuretics drug class. Exforge is the first treatment to combine Diovan (an angiotensin receptor blocker, or ARB) and the calcium channel blocker (CCB) amlodipine besylate, two of the most commonly prescribed medications for high blood pressure in their classes, into a convenient, once-daily single tablet.