Armstrong Pharmaceuticals: Primatene Mist

Cosmetic Act for Primatene Mist (epinephrine inhalation aerosol), 125 mcg per spray.

Specifically, the human factors (HF) study (G3) failed to demonstrate that the user interface supports safe and effective use of the product by intended users for the proposed uses in the OTC setting.

We also recommend further changes to the labeling regarding the mouthpiece instructions, including:

Applying Human Factors and Usability Engineering to Medical Devices, available online at:

Revise the statement of identity as noted in the November 22, 2016 information request:

Epinephrine HFA Inhalation Aerosol 125 mceg/actuation.

Satisfactory resolution of these cGMP deficiencies is required before this application may be approved.

The proposed epinephrine HFA inhalation aerosol includes thymol, which is not a qualified excipient for oral inhalation products intended for chronic use.

The submitted data do not support the proposed over-the-counter (OTC) use of epinephrine HFA inhalation aerosol for the temporary relief of mild symptoms of intermittent asthma in adults and adolescents 12 years of age and older.

The data from your behavioral study do not provide assurance that consumers clearly understand how to use epinephrine HFA inhalation aerosol.

To support approval of epinephrine HFA inhalation aerosol, you must provide data to support consumers' ability to use epinephrine HFA inhalation aerosol in the OTC setting, including the aspects of such use discussed above.

1. Revise the labeling to optimize comprehension and assess the revised label in a label comprehension study.

2. Conduct a behavioral (human factors) study with the revised label using the actual product (not a dummy product) to assess consumers' ability to use epinephrine HFA inhalation aerosol.

3. After conducting smaller behavioral (human factor) study(ies) to refine the labeling and potentially the device, conduct a randomized, actual use study with the revised labeling and proposed epinephrine HFA inhalation aerosol to rigorously quantify and evaluate complaints or problems associated with use of the product and characterize sources of user error.

3. Members of the Advisory Committee raised the issue of whether this product will be misused in consumers with asthma resulting in adverse asthma outcomes.

We also encourage you to request FDA advice regarding protocol designs prior to embarking on consumer studies.