FDA approves clotrimazole cream

September 16, 2008

FDA approves clotrimazole cream. The generic will be available in 15g tubes, 30g tubes, and 45g tubes.

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

"The approval of Clotrimazole Cream is another illustration of Fougera's robust product pipeline," David Klaum, senior vice president and general manager of Fougera, said. "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.