30 April 2018 - VivaGel NDA covers two indications for bacterial vaginosis – treatment and prevention.

Starpharma today announced that its rolling new drug application for VivaGel® BV including two indications, for the treatment of bacterial vaginosis (BV) and prevention of BV, has been completed, and the final module of the NDA will be submitted to the US FDA on Monday 30 April 2018 (US time).

The review of the VivaGel BV NDA by the FDA has already commenced and will be conducted as a priority review based on the fast track status of the product. The review is expected to take approximately 6-8 months from the completed submission.

Read Starpharma press release