Amphastar Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its wholly-owned subsidiary, Armstrong Pharmaceuticals, Inc., for its New Drug Application for Primatene® Mist (epinephrine inhalation aerosol).
A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. The CRL indicated that Armstrong should make further changes to the label and packaging for Primatene® Mist and then conduct another Human Factor validation study to assess consumers’ ability to use the product without the guidance of a doctor or pharmacist. Amphastar is evaluating the content of the letter and plans further discussions with the FDA.
Amphastar’s CEO, Dr. Jack Zhang, stated: “While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA during the post-action phase to address their concerns in the CRL by the middle of 2017 and bring Primatene® Mist back to the OTC market as soon as possible.”
The new Primatene® Mist is made with the same active ingredient, epinephrine, that was used in the original Primatene® Mist. However, the product’s new inhalation delivery system no longer includes chlorofluorocarbons (CFCs), which were phased out of various products worldwide as part of an international environmental treaty. Primatene® Mist also includes other important new features, including a built-in spray indicator and a pressurized metal canister that replaces the glass container used in the original Primatene® Mist product.