Shares of Amphastar Pharmaceuticals Inc. (NASDAQ: AMPH) fell on Tuesday after the company announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The letter was directed at the company’s subsidiary, Armstrong Pharma, for its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol).
For some quick background, 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.
The new Primatene Mist is made with the same active ingredient, epinephrine, which was used in the original product. However, the new inhalation delivery system no longer includes chlorofluorocarbons, which were phased out of various products worldwide as part of an international environmental treaty.
Excluding Tuesday’s move, Amphastar has vastly outperformed the broad markets in 2016, with the stock up about 44%.
Dr. Jack Zhang, CEO of Amphastar, commented:
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.
Currently, Amphastar is evaluating the content of the letter and plans further discussions with the FDA.
Shares of Amphastar were last trading down more than 9% at $18.48, with a consensus analyst price target of $21.20 and a 52-week trading range of $10.50 to $21.75.