Clotrimazole cream gets FDA approval

October 13, 2008

FDA has approved clotrimazole cream USP 1 percent for treatment of skin itching or burning.

Key Points

The U.S. Food and Drug Administration has approved clotrimazole cream USP 1 percent - a generic formulation that's similar to Taro's Referenced Listed Drug (RLD). The generic will be available in 15 g tubes, 30 g tubes, and 45 g tubes (NDC # 0168-0133-46). It is used to relieve skin itching or burning.

"The approval of clotrimazole cream is another illustration of Fougera's robust product pipeline," said David Klaum, senior vice president and general manager of Fougera. "With each product approval, Fougera reaffirms its commitment to providing safe, effective and affordable options to health care providers and their patients."

Fougera is a division of Nycomed US Inc.