ECI Pharmaceuticals, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

our review determined that your firm has selected an incorrect active ingredient to be included in the electronic listing file submitted to FDA.

Passage 2

the names of the active ingredients listed in the electronic listing file for both products do not match with the names of the active ingredients found on the copy of the labeling provided with the listing submission.

Passage 3

the names of active ingredients found in the electronic copy includes conjugated estrogens, while the labeling includes esterified estrogens. These active ingredients are different and not equivalent.