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# FDA Sets Review Period for Orbactive
- URL: https://www.fdaweb.com/fda-sets-review-period-for-orbactive/
- Published: 2016-06-17T12:00:00.000Z
- Updated: 2026-09-14T21:10:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135982

*Federal Register* Notice: FDA has determined the regulatory review period for Eli Lilly’s Orbactive (oritavancin diphosphate) is 6,539 days for extending a patent that claims the human drug product. Orbactiv is indicated for treating adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-06-17/pdf/2016-14353.pdf?ref=fdaweb.com)