Acne

New drug application submitted for Actiza

Published in Health and Medicine Week, January 19th, 2004

Connetics Corporation (CNCT) has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Actiza, an investigational new drug formulation of 1% clindamycin delivered in the company's proprietary VersaFoam delivery system, as a potential new topical treatment for acne.

In September, Connetics announced positive results from its phase III clinical trial with Actiza versus Clindagel for the treatment of acne. Based on pre-NDA discussions, the FDA indicated that this 505(b)(2) application qualifies for exclusion from a user fee assessment.

According to the National Institute of Arthritis, Musculoskeletal, and Skin...

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Source: Health and Medicine Week (2004-01-19)

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