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# Reject Cipla NDA for Descovy Duplicate: Gilead
- URL: https://www.fdaweb.com/reject-cipla-nda-for-descovy-duplicate-gilead/
- Published: 2026-04-22T12:00:00.000Z
- Updated: 2026-09-14T13:37:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161022

Gilead Sciences is petitioning FDA to rescind its decision to file a Cipla 505(b)(2) application for an apparent duplicate of Gilead’s Descovy (emtricitabine and tenofovir alafenamide) tablets. The [petition](https://downloads.regulations.gov/FDA-2026-P-4112-0001/attachment%5F2.pdf?ref=fdaweb.com) also asks the agency to refuse to grant the Cipla product an A rating, reflecting a determination of therapeutic equivalence, should such a determination become relevant.

The petition argues that Cipla should have submitted an ANDA rather than a 505(b)(2) NDA because the only apparent difference between the Cipla product and Descovy relates to the amount of tenofovir alafenamide fumarate (TAF) active ingredient in both products. It says the ratio of fumaric acid to TAF is 1:1 in Cipla’s product and 0.5:1 in Descovy. “This difference does not cause Cipla’s product and Descovy to have different active ingredients” for several reasons, Gilead says.

“In the absence of any difference from Descovy that would preclude Cipla’s proposed product from being submitted as an ANDA,” the petition says, “Gilead requests that FDA rescind its decision to file Cipla’s 505(b)(2) application for an apparent duplicate of Descovy.”