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On November 6, 2024, Amphastar received a secondary complete response letter (CRL) from the Food and Drug Administration (FDA) for its generic teriparatide ANDA, AMP-015, following months of delays surrounding the submission of the drug. Analysts expressed disappointment at the Company’s announcement and Amphastar has still not responded to the CRL.
Following this news, Amphastar’s stock price fell by $7.31 per share, or approximately 13% to close at $46.09 per share on November 7, 2024.