Teva Women’s Health, Inc.: progesterone

Please refer to your New Drug Application (NDA) dated and received on April 30, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for progesterone vaginal ring.

We also acknowledge receipt of your amendment dated February 18, 2011, which was not reviewed for this action.

The particle size distribution of progesterone is considered to be critical for the consistent release of progesterone.

To address this concern, we continue to recommend that you conduct, prior to approval of your product, a randomized, active-controlled clinical trial to evaluate the efficacy of your product in women 35-42 years of age.

The trial should be adequately powered to demonstrate sufficient retention of efficacy in the progesterone vaginal ring arm when compared to the active comparator.

Details of the trial should be agreed upon with the Agency prior to the conduct of the study.

Satisfactory resolution of these deficiencies is required before this application may be approved.

8. Provide English translations of current approved foreign labeling not previously submitted.

If you have any questions, call Karl Stiller, Regulatory Project Manager, at (301) 796-1993.