FDA Citizen Petition
Docket No. FDA-2025-P-6074
To whom it may concern,
The undersigned submits this petition under the Federal Food, Drug and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs to request the Commissioner of Food and Drugs to take a form of administrative action.
Section A: Action Requested
I am requesting the INDICATIONS AND USAGE section of the Full Prescribing Label for Premarin tablets for dosages 0.30 mg and 0.45 mg be re-written as follows:
From:
INDICATIONS AND USAGE
PREMARIN is a mixture of estrogens indicated for:
- Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
- Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
- Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure
- Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease
- Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only)
- Prevention of Postmenopausal Osteoporosis
To:
INDICATIONS AND USAGE
PREMARIN is a mixture of estrogens indicated for:
- Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
- Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
- Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease
- Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only)
- Prevention of Postmenopausal Osteoporosis
Section B: Statement of Grounds
The reason for the change is to reflect the actual efficacy of Premarin 0.30 mg and 0.45 mg tablets.
To say that Premarin 0.30 mg and 0.45 mg tablets are treatment for hypoestrogenism is an exaggeration of Premarin’s efficacy. Please see section INDICATIONS AND USAGE in Attachment 1.
Given that in 2013 the FDA approved Duavee, a drug that contains Premarin 0.45 mg combined with a SERM*, for hot flashes and osteoporosis only, it doesn’t make sense that Premarin 0.45 mg by itself could have more indications than Duavee. Please see section INDICATIONS AND USAGE in Attachment 2.
*(SERM = Selective Estrogen Receptor Modulator)
If the FDA did not approve Premarin 0.45 mg and an additional SERM drug for hypoestrogenism than Premarin 0.45 mg alone cannot be treatment for hypoestrogenism.
Currently, all dosages of Premarin are FDA approved as a treatment for hypoestrogenism. If Premarin 0.45 mg alone is not sufficient to treat hypoestrogenism than Premarin 0.30 mg alone is also not sufficient to treat hypoestrogenism.
The FDA has been remiss in not updating the Premarin label to remove the Indication for Premarin 0.30 mg and Premarin 0.45 mg as treatments for hypoestrogenism.
Therefore, I am requesting that the FDA update the INDICATIONS AND USAGE for Premarin 0.30 mg and 0.45 mg tablets to remove the Indication of “Treatment for Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure”.
Section C: Environmental Impact
According to section § 25.30 General subsection (a) and § 25.31 Human drugs and biologics subsection (a) there is no requirement to provide an environmental impact.
Section D: Economic Impact
not applicable at this time
Section E: Certification
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.