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7 months ago
BRIEF-Amphastar Pharmaceuticals receives Complete Response Letter
December 27, 2016 / 11:57 AM / 7 months ago

BRIEF-Amphastar Pharmaceuticals receives Complete Response Letter

1 Min Read

Dec 27 (Reuters) - Amphastar Pharmaceuticals Inc :

* Amphastar Pharmaceuticals Inc - CRL indicated that armstrong should make further changes to label and packaging for Primatene Mist

* Amphastar Pharma - intend to continue to work with fda to address their concerns in CRL by middle of 2017 and bring Primatene Mist back to OTC market

* Amphastar Pharmaceuticals receives complete response letter for Primatene Mist

* Amphastar Pharmaceuticals Inc - Amphastar is evaluating content of letter and plans further discussions with FDA

* Amphastar Pharma - CRL indicated that armstrong should conduct another human factor validation study Source text for Eikon: Further company coverage:

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