Home / Acne / Novan Has Guidance Meeting with FDA on SB204

Novan Has Guidance Meeting with FDA on SB204

Novan, Inc. is eyeing an additional pivotal trial for its investigational treatment for acne vulgaris, SB204. The company concluded a guidance meeting with the FDA regarding SB204 in which the agency advised that an additional pivotal trial should be conducted. Given the need for the additional clinical study, the agency treated this meeting as a guidance meeting rather than a pre-NDA meeting. The Company anticipates receiving written minutes of the meeting within the next 30 days.

“We had a productive guidance meeting with the FDA regarding SB204. The meeting provided important clarity with regard to design for any future pivotal trial,” stated Kelly Martin, Novan’s interim Chief Executive Officer. “We intend to update the marketplace as to the next steps for SB204 after having had the chance to review and verify the final FDA minutes and incorporate that input into the overall Novan plan.“

About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

Check Also

A feasibility study for a triple-blind randomized controlled trial investigating the effects of oral isotretinoin on mood and quality of life in patients with acne vulgaris.

DOI: ced.13284  PMID: 29030873   Isotretinoin is used in the treatment of severe acne vulgaris (AV), but …

Leave a Reply

Your email address will not be published. Required fields are marked *