Acne

Company receives FDA nonapprovable letter for Velac

Published in Medical Letter on the CDC and FDA, July 17th, 2005

Connetics Corp. (CNCT), a specialty-pharmaceutical company focused on dermatology, announced that the U.S. Food and Drug Administration (FDA) has issued a nonapprovable letter dated June 10, 2005, for Velac (a combination of 1% clindamycin and 0.025% tretinoin) Gel, an investigational new drug formulation for treating acne.

The only issue raised in the nonapprovable letter was a positive carcinogenicity signal that was detected in a TgAC mouse dermal carcinogenicity study.

"We are disappointed in the FDA's decision. As discussed during our first quarter earnings call on April 26, [2005,] we were particularly disappointed that FDA did not notify us of...

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Source: Medical Letter on the CDC and FDA (2005-07-17)

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