> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Grants Duavee NCE Exclusivity
- URL: https://www.fdaweb.com/fda-grants-duavee-nce-exclusivity/
- Published: 2017-06-13T12:00:00.000Z
- Updated: 2026-09-14T22:29:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138918

FDA says it has approved five-year new chemical entity exclusivity for Pfizer’s Duavee (conjugated estrogens; bazefoxifene acetate), rendering moot a company 9/30/16 petition requesting the action in light of a DC federal court decision in *Ferring Pharmaceuticals v. Burwell*. The agency [response](https://www.regulations.gov/document?D=FDA-2016-P-3082-0026&ref=fdaweb.com) says that at the time of its 10/3/13 approval, Duavee, a fixed-combination drug product, contained one previously approved active moiety and one previously unapproved active moiety.

Consistent with the agency’s interpretation of the relevant statutory and regulatory provisions, the letter says, FDA determined that Duavee was entitled to three-year exclusivity. That decision led to the company petition.

With the government’s decision not to continue with an appeal of *Ferring*, the response letter says, and wanting to minimize the possibility of further legal challenge, FDA has determined that Duavee is eligible for five-year exclusivity, that will expire 10/3/18.